ML20214V468
| ML20214V468 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 03/21/1973 |
| From: | MEDTRONIC, INC. |
| To: | |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 1146, PROC-730321, NUDOCS 8610020307 | |
| Download: ML20214V468 (32) | |
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ModtronicMLaurens-Alcatel Model 9000 Isotopic Pulso Generator CLIIIICAL ItWESTIGATION PLAN by Modtronic, Inc.
March. 21, 1973 l
D 8610020307 860811 REG 3 LIC70 PDR SNM-1156 i
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INTRODUCTION The overall objectives of clinical evaltation at Medtronic are to determine the safety and officacy of new products and to promptly identify any unforeseen clinical problems associated with the use of these products.
Within the framework of these general objectives, it in our intention that the performance in living humans of Model 9000, a nuclear powered pulse generator be compared to that of the closest equivalent bipolar demand unit operating on chemical cells.
Compariscns are to be aimed specifically at:
1.
random failure rates of c1ccironic components, 2.
adverse side effcets and ot! a possible unex7ceted developments associated with the major 2nctors and interfaces of the overall pacemaking system, and 3.
longevity, as reficcted in a specified percentile of the end of the pulso generator life distribution.
The minimum time required to attain objectives 1 and 2 is catimated to be 24 months from the time of the first implantation.
Longevity comparisons will necessarily involve much more time than this, possibly ten years or more, in view of the theoretically high life expectancy of the isotopic power cell.
To allow for the limited rate at which patients in specified categories become available, it will be necessary to build up the sampic gradually throughout the first 24 months of the study.
As will be explained in the text which follows, the recommended rate of implantation of the nuclear device should be at least 960 experimental units over a two year period.
The rate of implantati0n of the control group should be two or three times this level -
both as insurance against follow-up difficultics and as a means I
of achieving as much precision as possibic in failure rate comparisons.
In the text to follow, the data collection prceedures, the statistical ba kground of the proposed test procedure, the recommended sampling rate and the proposed criteria for pa'.icnt selection will be presented in as much detail as seems reasonable at this stage of the project.
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II.
_ DATA COLLECTIOU PROCEDIBES Specially trained personnel will visit cach physician when he becomes a participant in the study.
These individuals will ensure that cach participant has a full understanding of the study, answer any. questions the participant may have concerning the study and ensure that the participant obtains and reports complete, unbiased and reliable data.
They will ensure that thc Registration and Implantation Da ta Forms (Exhibit II) for cach patient are completed and returned to Medtronic.
The Registration and Implantation Data Form (Exhibit II) and the Follow-Up Data Form (Exhibit III) will bc included in the product literature which will accompany each MedtronicTM Laurens-Alcatel Model 9000 Isotopic Pulse Generator.
In addition, Mcdtronic will mail out Follcw-Up Data Forms (Exhibit III) overy three months during the first year following implant, and overy six mtnths thereaf ter until completion of the study.
The physician will be asked to completc the forms and return them to Mcdtronie.
Our specialists will be contacting the participating investigators at 3 cast three eines a year to review the program with them.
During these visits particular interest will be given to obtaining:
1.
Summary of clinical data in cases of adverse offects or malfunctions related to the pacemaker system including loads and opinion as to the nature and causes of these.
2.
An ovaluation of the safety and reliability of the pulse generators and the procedure for its use (s ta temen t summarizing side offects, t
toxicity, device malfunction, degradation or failure).
i Medtronic will immedia:cly report any problems to the Atomic Energy Co.va.ission stating the naturo of the problem, its i
rela tive frequency and possible corrective ac tion.
Medtronic will submit a Status Report (sco Exhibit A) to the Atumic Energy Commission cycry six months until the study is terminated.
l The evaluation of the incoming data will be performed according to scientific ntatistical principles as outlined in the S ta tis tical Proceduros.
l l
F.
. I' j
,. EXHIBIT A. - CONTENTS OF STATUS REPORT j.
q (To be submitted overy six months to the Licensing Agency by Medtronic) k This report will contain' the up-to-date status knowledge of the clinical evaluation in a summarized form.
An overall
)
tally of the study will be supplied indicating the total number j
and durations of Model 9000 implants, the number of Model 9000 j
implants por physician / hospital, the total number of-control device implants, and the number of control device implants per
)
physician / hospital.
The control devices will be grouped by model
~
number.
There will be an overall tally of all pacemaker systems l
in the study which failed to perform as expected, including the nature of the failure.
There will also be a tally of all patients r
in the study which at that time are lost to follow-up and the reason why they were lost to follow-up.
A statistical evaluation of the pulse generator performance will be supplied.
i III.
STATISTICAL PROCEDURES (a ).
The Estination of Monthlv Failure Probabilitics:
The probability, p(t), of a component failing at random E
sometime during a period of t months is related to the one-month failuro probability, 6, by the equation P(t) = 1 - (1 - 6 ) t (1)
)
{~
When equation 1 is expanded about acro in a Taylor scrics, it is readily apparent that for small values of G the relationship can be closely approximated by the simpler expression, p (t) c= t G,
(2) provided t is not unduly.largc.
For example, if 6 6 0.002 (as t
existing data atrongly indicatos (1)) and if t is sot at 24 months (which in the present proposal), then p (t) will be es timated to within 1 css than 2.4% of its true value by means of equation 2.
Furthermore, although the total number of failures, X, which e
occur within a given sampic of size n over t months is theoretically a binomially distributed random variabic, the typically small value of p(t) justifics the use of the Poisson approxima tion (2):
i
-ntO P(x = y} =
e Wo?y (3 )
c
't!
o o
i Since E(X ) = nte, the expectation of the total observed t
failures, k.= 2~x, in the combined sample of nr units is given by r
E(k) =[ntG
= _nr (r + 1) G,'
(4) t 2
implying that the appropriate unbiased statistic to use in estimating (p is A6
= 2k nr (r + 1)
(5)
Utilizing the asnimption that k is also distributed as a Poisson variate with paramotor nr (r + 1)G /2 and that k
. 7'
,m N
{5 l --
^1!
(6) m s.
l happens to equal the cumulative probability of a X variate with 2k + 2 degrcos of freedom (2), we obtain the convenient expression for the upper 1 - X confidence limit (3) for G,
I r
t*M,1Ati Mr(rr )
(7) f Examnic 1:
Suppose that an implant rate of 40 units por month for 24 months icd to a total of 12 random failures.
Then the unbiased estimate of 100 G would be 0.10 por cent por month and the upper 95% confidence limit for 100 G would bc 0.162 por cent por month.
I i
l 03 ).
The Entimation of Pulac Generator Loncevity:
l P
Pulse gonorator failure may be attributed cither to g
l clectronic component failure, which is randem in timo (1), or l
to power sourec depiction, which increases in probability with timo from implantation.
Because chemically pcworcd cells arc cicctively replaced before the probability of ec11 depletion attains a detectabic magnitude, each succession of functioning devices within the same patient may be treated as a singic device
,with a non-depicting power source, for the purpose of catablish:.ng rollability conparisons.
The isotopic cIl has such a high theoretical li:!c expectancy that it, too, will likely behavo an a non-depleling power sourco for many years following implan ta tion.
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Now, as long as the probability of cell depletion remains insignificant, the cumulativo probability of generator failure will be solely dependent upon random component failures.
This of course implies that longevity estimates have no meaning whatsoever insofar as elective replacement policy is concerned.
However,. they could provide interesting additional criteria for comparing the two types of pulse generators.
The term " longevity" itself is somewhat ambiguous, in that.
it may refer cither to a specified percentilo, to, or to the-mean, E (t), of the time-to-failure destribution.' The first.
two years of failure data in the proposed study will allow us to calculate interval estimates for either one of these measures of longevity.
For exag.plo, to obtain a lowcr confidence limit on E(t),
uc may invoke -the well known f act (4) that whenever the distribution of t is given by dFf p (t) = 1 - 6 (8)
-1 then E (t) =
'd' (9)
Comparing this with equation 1, we find that f= -in(1 - G),
and, therefore, that
[
/M (1 - G)3-f
),
(10)
E (t) =
Now; since E (t) is a monitonically decreasing function of 6, and since G* (as defined in equation 7) is an upper 1 -- oc confidence limit for G, it follows that E* (t) = [-/Mb~G)
(11) provides a lowar /-M confidence limit on E(t).
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q p
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Finally,by inverting equation 1, and repeating the same line of reasoning, we obtain the lower ;-n confidence limit for t,
p t * = In (1 - p)
(12) p in (1 - G*)
where p is the specified percontile of the time-to-failure dis tribu tion.
Example 2:
Using the same hypothetical data as in examplc 1, the lower 0.95 confidence limit on the life expectancy would bc
[ *(t )
f ~ lop (I
.o o s t a.) h ~'
=
= 616.8 months, or 51.4 years.
Also, with confidence 0.95, we could claim that at least 50% of devices would still be functioning in 35.6 years from implant (again, assuming no ecl1 depletion).
(c).
Statistical Basis of the Tact Procedure:
The hypotheses which provide the basis of the proposed (significance testing procedures may be stated as follows:
H: 6, 6 G, and H,: 6. 7 G, whero 9, and 66 are the monthly failure probabilitics of the control unit and the nuclear powered unit, respectively.
In other words, the working hypothesis will be that the nuc1 car unit is no more likely to fail than is the control device.
Competing with this hypothesis will be the alternative possibility that the nuclear unit does have a higher random failure probability.
On the supposition that the implant rates of the experimen tal and cc. trol unit are to be n and en units per month, respectively, 2 - k, where k1 an appropriate test statistic is given by D = ck t
and k2 are the correspondincj observed total failures in the control and ex:)crimental groupa.
The campling dic tribution of D is symmetrical about acro only when O.u Q and c = 1.
In the general caso, its probability mass function is given (2) by f[D=y)=
C._. h, m)[d 7">" 1~in -Y 03.)
y,. y
>n (n,- y ),
g
.....r u ~n
o
.o
+
In Table A are listed the exact values 'of Du corresponding to certain selected values of G,,
cd and n, when c = 1.
Since those vary with G, the true significance level of the test will be known only approximately at the time the test is applied.
The power curves of the tes t corresponding to the same celected values of 6,, OC and n, are shown in Figurcs A and B.
The probability distribution of D when c 71 is apparently not known and so we are unable to generate a table of test critoria for this case.
However, if we let c e co, which is the same as assuming G, will be known at the time of the test, then the test statistic reduces to D = k2 - nr (r + 1)/2, for which critical values and power curves can be readily derived, using the relationship between a cumulative Poisson and cumulative Rf distribution referred to in expression (6 ).
One such caso is illustrated in Figure A.
It is thereforo possible to estimate the appropriate rejection critorion and associated powcr curve for finito e grcator than 1.
(d).
Sample Sine Considerationn:
Theoretically, by fixing the desired sine of the Type I crror, Ct, und by specifying the maximum allowablo Probability,
/1, of failure to detect a truc difference in monthly failure rates as small as some stated amount, 41, it is possible to compute the optimum monthly rate of implantation.
Unfortunately, the non-central distribution of the difference between two Poisson variates is exceedingly difficult to handic analytically and changes not only with the true failure rate difference but also with the absolute failure rate, 6,, of the control sampic.
Ilowever, by specifying various possible values of n and G,, it is possible, with the aid of a computer, to generate families od power curves and to interpolate among these curves for the optimum choica of n.
In the case of the present study, 100 6, was catima ted to be about 0.15% por month and both the c( and g errors woro specified at 10% for a detcetion capability of 0.15% difference por month over the first 24 months of the s tudy.
Reference to the power curvos of Figure A reveals the corresponding minimum necessary implantation rate to be 40 nuclear units por month.
At this campling intensity for two years, the nuclear pcwcred units must demons trate an excess of 0 f ailures more than the control units before they may be declarad significantly less reliable.
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(c).
Exocrimental Design Considerations:
i The physician / hospital / patient population is insufficiently characterized at this early stagc~ to justify specific design recommendations.
It is therefore planned tha t, concurrent with the initial implantations, a three to six month reconnaicsance study be carried out for the purpose of identifying potentially significant factors of the patient population, hospital facilitics and surgical procedures that could possibly bias or otherwisc invali.i to the study.
During this exploratory phase of the program, deliberato efforts will be made to solicit physician co-operation in structuring the study, as much as is feasibic, according to conventional principles of sound experimental design.
l Priority consideration will be given to the problem of matching patients rocciving the nuclear unit with their counterparts bearing the conventional device cc controls.
Ecyond this, recommendations portaining to the decign of the experiment must await the findings of the pilot study.
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IV. SU O'ARY
_t Consistant with the overall objectives of Modtronic's clinical evaluation programs, Project 238 will concern itself with the establishment of the safety and officacy of the nuclear powered pacemaker through a carefully planned and executed long term experiment involving a comparabic chemically powered unit as the standard of comparison.
During the first two years of the study it is proposed that the nuclear units be implanted at a rate of 40 por month for the purpose of comparing the relative failuro rates of the two devices.
This rate of implantation over a two year pericd should maho it possible to detect real differences in failure rates between the tw6 devices as small as.15% por month at the 90% confidence lc.ve l.
Personnal will be specially trained to work in close contact with the co-operating surgeons and to encure that all data forms, including. follow-ups, should be cceplete and impartial records of pulse generator performance charac:cristicc.
Relevant resul:3 frar, these. data forms will he interprotcd and transmitcod to the A.E.C. in a Status Report semi-annually throughout the life of the study.
In cddition, any unforeceen problems of significan:o which might ar i:. c in c;nnection.<ith ch; performance of the isotopic unit will be promptly relayed to the A.E.C.
together with an explanation of its cause and the steps recommended by Mcdtronic for its correction.
At the end of this two year period a major ccmprohcasive report will be submitted, surT.arizing the principal findings of the investigation.
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4 REFERENCES 1.
Mcdtronic, Summary of Studies and Experience Concerning the Service Life of Mcdtronic Implantable Cardiac Pulse Generators, Medtronic, Inc.
Minneapolis, Unpublished Manuscript. 1972.
2.
- Johnson, N. L. and Kotz, S.,
Discrete Dis tributions, Houghton Mifflin Company, Boston, 1969, pp. 114, 115.
3.
Mood, A. M. and Graybill, P.
A.,
Introduction to the Theory of Statistics, McGraw-Hill Book Company, New York, IS63, p. 256.
4.
- Chiang, C.
L., Introduction to Stochastic Processes in Diostatiatica, John Wiley & Sons, New York, 1968, p.
10.
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i' Table A.
Critical values of the test statistic D., = k
-k for testing the difference between 2
the monthly failure probabilitics of the nuclear and the control dcvices.
Monthly I nlantation Rate
/CO 6, 30 40 50 60 70 80 c4=005
.10 7
9 9
10 11 12
.15 9
10 11 12 13 14
.20 10 12 13 14 15 16 Cl.= C./0
.10 5
6 7
8 9
9 k
.15 7
8 9
9 10 11
.20 8
9 10 11 12 13 l
l I
1 l
l l
L_
I 1.00
/E D
C B
g-A l/ /g p
0.90 j
/
/
0.80 j
i I
I 0.70 I
[
[
FIGURE A. Power Curves i
j I
/
/
For a = 0.10 l
l
/
0.00 j
j
---0:
Unknown
-0:
Known 1-0 l
l
/
d : True difference in 0.50 failure probabinties l,
(% per (nonth)
I f
1-g : Probability of detection I
t 0.40 g
i LEGEND I
j (A) di = 0.15 n = 40 (B) d i = 0.10 n = 40 0.00
/-
(C) di = 0.15 n = 80 (D) ei = 0.10 n = 80 I
(E) 0 : = 0.10 n = E0
/
I om
/
/'
O.10 2
e 3 0 j
I D
C A
1*
/
/
0.90 f
/
/
0.80 0.70 FIGURE B.
Power Curves For a = 0.05 0.00 LEGEND "0
(A) s i = 0.15 n = 40
)
(B) Oi = o.10 n = 40 0.50 (C) Oi = 0.15 n = 80 (D) 0: = 0.10 n = SO A9e E?..k
{}efr'.,,'hien1 0.40 v
(
0.30 0.20
)
0.10 n r3 o ne, 0 10 0.15 0.20 0.25
-)
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.L '-f G T-MEDTRONIC
'.1 LAURENS-ALCATEL MODEL 9000 i
ISOTOPIC PULSE GEZERATOR PROTOC L i
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DATED:
MARCH 21, 1973 I
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i I.
INVESTIGATICSAL PRCGRAM:
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A.
Title._
'EDTRONIC Laurens-Alcatel Model 9000 Isotopic Pulso Generator Study.
f 3.
J1u rron e.
The purpcso of this study is to cvalua 0 the operatin~ life of this n.ulse c.enerator and to evalunts tha c;ston v
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a generator as outlined in this protccol.
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, cha nav.: ;,.: e n cen..;e r e m y avs t ;.a c ic t re m Modtronic since 15M.
l m_
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uv..uru2 u.c r. e c c, u....... u,.m c..,
....u..~.v r.vu...u. m treatrant of choice for heart block and several other rhythm d 4 - 's ".'a~a.. ~ a.
T'.r' v, 'r.a". c M e n ir.. # e. n ~~.~e '. d.. ' n c
~- s..e 2. -
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n' r
o u-se The value of this rcdo of trentr.ent is documented in numerous nublications in the medical liter'.ture.
The ph'.rsician r;spensibic L
tor t.ne stuuy ic a
. a.c.1.3lar wit,n :ne first three references 21sto;. In g
Exhibit -
Como.leto technical data on this c.ulso c,enorator as a whclo and on its isotepic po;er supply in particular, on radinticn lav212
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Thin pu!.ca generator has boer uced in patient:, in Eurc u
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-.v, The re.sults of the first 101 ir.alant.tions in Eurono rc recertsa to the European Congress of Carc'iclogy in September 1973, b y ~.;t f a n.2,
et al (Reference 4, E::hibit I.)
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e Model 90C0 Isotopic Pulco Generator will ba i:~. plant a.; follo.-is:
p
,_j3 e.j n. e., -._e,_.... : o.,
.g,,. 4.. u c......-.,u..,_..
..... v.-. s.. 4...
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vill have chronic heart b)cek or ot'..or cardu.c rhy t.:.
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s requiring.an implantable pacemaker system.
They w.ill ha of sound mind and 18 years of age or more.
The upper age l'imit will ba datcr-minedbyalifeexpectancyin-excessoftenyears.{Patientswith coexistent diseases which might limit the life expectancy to less than ten yearc will not be selected for this study.
In' addition, efforts will be made to select' patients who are reliable sdb"oct: and who J
have a record of stable residence in the community >such that the patient is.willing to ccoperate in, and is likely to remain available for the long term follow-up required for this study.
s 1
.2.' Duration of Studv.
Ur.lcss results indicata otherwise, implantauf ens under thic s:udy will continue for two (2) years.
l Patient follow-up and recovery proceduros will continua during the i
life'of the patient and until the pulse generator is recovered.
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'owered pulse concrators, a series of comparabic control patients e
with innlanted Moctronic bipolar demand pulsa generate w f c l.c.;a ;..
Th_ con: ol :mpic.nts. :.12 ca pcrcor.ned using nr.2 cama
}
procedures for patient selection, medical procedurcs, follow-up, and reporting.
2 i
4.
t.'ed i ca l P rocedures.
A medical evaluation of the cariant
]
will be performed and documented.
Myocardial leads (Medtronic Model 5814), will he used with one of the several surgical approcches available to either the icft or right ventricular surface of the heart.
The pulse generator will be placed into the subcutaneous tissues of the abdomen or the chest wall.
If this pulse generator is replacing another, the existir.g l
lead c ster ma.v be usea.
- . the aura. :.. cal n. rocac.ure ; n o r p a c :.n c.,
nuloca rdial leads are contraindicated for the r.atiant bac:use of a
the risks of a thoracotom.?, thcn other surcical techniquaz or J
ondocardial trancvanous 1 cads ru;y bc used.
In any cven:, the i
lands uccd must have a ccnncerc
- hat is ccapat nia.ath
'.; pulso generator or compatible with a standard adaptor used with the pulac 1
gencrator; splicing of leads will not be allowed.
5.
y_o_j_i_c_a l__ Ex n M n a t i o n s.
At the time of implantation, stitaulation thre sholds will bc maasured in accordance with gancrally accen.t.ed procedurcu of pacmacker implantation.
A. t a n a n. n. r e n. ri a t e interval following implantation, data vill be secured and r.f c part of the record indicating pacemaker function na obcarv,d.;ofer; and follcwing application of the tacnet to induce asynchrencu
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.m.
.o Lr
_.u m
- p.,
i U
~ j opOra'~.lon or t.ne device.
Ta,ls incormation wl.t1
.ne coc cantea, en the Registration and Implantation Data form for both the pctienc.
in the study and t.he control crou., (a co.')y of which is attcched nu s
p../.t.12 D 1..
1 r )'.
Prior to release ' from the-hospital, every three conths during-the first v. ear toAlcwina. in.oAantat'.cn anc, cuery six mont.ns thereafter, the patienti.till roccive a follcw-up examination vhich o.
wil. l incJ.uac t.ne securing or an e.3 cctrocaruicgram cnc c.ascrving pacemaker function before and following application of tac magne:
to induca as'Inchronous c.ceration of the device. - U.oon re.coval, for*
whatever reason, information on the reason for rencval and, where applicablo, findings of autopsy will be secur:-i.
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Identification of Patient.
Each pdrient shall ce~v an I.D. Card ar.d Bracclot on his or her person at! all times
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3 may engrave information on bracelet or picco of jewelrv of his c-cwn enoice.
These will be furniched to the patiedt nricr to be A~ c~
discharged from the hospital.
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The I.D. Card will be a wallet-sized, plastic-la:nin:ted card, ac follows:
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Sac. Scc. No.
PeccJ F.ste i
6 Daw of Implu.t Type of 1.ea.:s P4carnakcr Seria: Number MC 7 343a I
2.
The Bracelet (or other piece of jewelr'-) will be metal and cngraved as follows:
I have a nucicar pacemaker - in emergency, Front hospitalization or death call- (emergency
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1.
I.D. Card and Bracelot carr" instructions for notification of doclot and institution in the ' vent of emercenc.e, e
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In Case cf Cmergen0"r hCS.Ditali2ation or death'* the ps'.tient Cr a J
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w..u and indicate that the call concerns "P ro -i e c t 233". The enerator o
upon receipt of a call with reforcnce to " Project' 23S",
e 11 have stianding instructions to contact the physic 4-responsicle for
- h e.
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tainad i:- Exhibit VI.
The doctor or his designate cili respond
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permission for remova.,, the patient wl.,1 grant permission for re-moval and recovery of the isotopic pulse generator cy sig.-ing a Oncr Ca.c _4n "u.".e 2
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the Donor Card will be retained in the patient's acdical records.
Tn.e c.attent wtt1 n.o in:.crmcc that tn,a permission may oc as creae s
as incicateC in 11nOS (C) anG
(,D j On t.ne CarG or u,n a t '. O ~J.27 O?
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The recovered pulse generators will be returned to c,,.ca,tronic for reliability assurance analysis.
The responsible physician-will secure agrec=cnt 4.
by the patient to abice by the following instructions:
(a)
The patient will at all times carrr the I.D. Card and Bracclet (or other cnaraved piece of jewelry).
~
(b)
The patient will at all times carry on his or her person the Donor Card.
(c)
The pati:'n; will notify the hospinal of an f change of his address er telephonc nuncer ^
.or if there is any change in regard to his next of kin or other person to be notified in case c: enorgencv.
(d)
The patien: will notify the spproprinne 11ccnsing authority prior to anv outside of the United States.
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EXHIBIT T References 1.
Chardack, Willima'M.:
Cardiac Pacemakers and Heart 31ock.
In Surcerv of the Chect (Chapter 38), Second Edition, Editors John H. Gibbon, Jr., David C. Sabiston and Frank C.
Spencer.
Publishers - W.B.
Saunders Co.,
Philadol-c.hia* 1969.
2.
Chardach, Willian :..:
Cardiac Pacemakers.
In Davis-Christopher's Textbook of Surcerv (Chapter 53), Tenth Edition, Editor David C.
Sabiston, Jr. Publishers-W.B.
Saunders Co.,
Philadelphia, 1972.
3.
- Furman, S..and Escher, D.
J. W.:
Principles and T2chni :es of Cardice Pccine.
Now York, Harper and Row, 1970.
4.
Laur:ns, P.,
- Piwnica,
.a., Raidemaister, C.
and Rabago, C.:
Applications Cliniques D'un Stimulateur Cardiaque Radio-Isotcpique (Abstract). -Presented at the Congress Europten
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MEDTRONIC LAURENS-ALCATEL XODEL 9000 ISOTOPIC PULSE GENERATOR Plecco complete this form.
Retain one copy for your records and return one copy to:
Medtronic, Inc.
3055 Old Highway 3 Minneapolis, Minnesota 55418 (olease u.rint or tv.o.o) 1 Patient Name Last Firct Initial Social Security No.
Hospital Record No.
Home address City State Zip Area Code and Telephone No.
Business address Citi-Sta:e Z;p Are; Code and Talephonc So.
Namo, address, and tolaphone of perscn (s) to be contac cd if pttient cannot be located:
City State Zig Area Code and telephone No.
Nama, address, tnd telephone of cerson(s) to be centacted if patient cannot be icentcd:
City State Zip Area Code and telephone No.:
Relationship to Patient 2.
Physician (s) and Hospital:
I Name Office Address City State Zio Area Code and Telephone No.
3.
Pulse Generator:
Model No.
Serial No.
Fuel Capsule ::o.
Batterv No.-
Date of Implant __
Bipclar or Unipolar Placement:
s ub cu tane ou s/s ucmu s cu la rf in t ramu s culc r/ s t ha r right/left pactcral/ abdominal /other existing /new pocket Stimulation rate:
with Magnet aithcut l
l
- - =ts
,e,s q,\\
E !
~s Threshold measurements:
constant current nulse width other method (describe) :
~
i Equipment used to take thrcc'.cid i
n Previous implant:
Yes/No If yes:
Manufacturer Model i
Date of imul. ant i
Why removed i
Total number of previous implants 4.
Lead:,
t Manufacturer Model No.
Serial No.
(for new leads only)
Date of implant Placement:
Epicardial:
right/left ventricle
- m.,n -u..o_ _,..1 m,/n....,...c..._ n._...e
-o Endocardinl: vain uced Previous leads (if applicchie and available):
Endocardial 5 umber, :.odels, and implant dates?H..
in; remoccf upicardia.1 Number, models, and implant dates?How many removed S.
Clinical data:
Patient'c age Soy Race Height Weight Right handed /Left handed Etiology of arrhythmia Kind of arrhythmia Previous druu therarv for arrhythmic N
s Associated diseases Temporary pacing (for initial implants only) yes/no j
Anesthetics used-during sur~cr.v v
Antibiotics:
locally / systemically /none i
Cortisones or other anti-inflamatory drugs:
locally / systemically /
none Was pocket drained:
yes/no If yes, how long Did complications or adversc reaction occur in:
paccanker/ lead surgery 1
If.vos, treatment Corr.cnto 1
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EZHISIT III s
FOLLO?!-UP 2ATA FORM MEDTRONIC LAURENS-ALCATEL MODEL 5000 ISOTOPIC P'g\\
LS3 GENERATOR Picase complete-this form.
Retain onc ccpy for y\\our records and return one copy to:
Medtronic, Inc.
3055 Old Highway 8 Minneapolis, Minnesota 55413 (Please print or type) l.
Patient Name Last First Initial Patient Hospital Record No.
Pulso Generator Serial Number r
Data of Irplantation Date o f Follow-Up 1:anc of Physicina Name of Hospital Telephone No.
Address 4
City State Patient has I.D.
Card:
Yes No Patient is wearing Bracelot or its Equivalent:
Yes No Contact maintained with patient:
Yes No 2.
Pulse Cenbrator Functicn:
b
- Satis factory S timula tion Rato -
With magne:
Without magna:
- Unsatisfactory Commen s u
3.
Summary of medical examination, including labora;ory data (vearly intervals):
4.
Reno ; ;l Information:
- Reason for Removal:
- Autopsy finfings, if applicable
.)
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STATEME'O The patient has been. informed that the it. plantation of the isotopic pacemaker is licensed only for t'.ie purpose of clinical investigation. He has becn apprised of the appro:.irato i
I nu:';5er of isotoP c naceraahers used on other patients and the results so far obtained ' tith this procedure. He has also been I
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maker; and the patient's obligations for follo.:-up, recocal and recovery of the pacemaker.
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-I Date:
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3 EXHIBIT V Language to he Added to Hospital's l-Form for Patient's Consent for Surgery
\\
In the event of my death, I also consent to, authorize and request all the appropriate medical s'nd surgical operations and procedurcs in order to remove and ro' cover the pacemaker including the removal.of the pacemaker sy' stem and surroundin~ tissue, if necessary< and a.n.pronriate procedures e
for disposal of the pacemaker by public health authoritics and the licensing authority. I grant p'ublic health authcritics and the licensing authority ~ access to my medical records for purpos:s of facilitating the Lecovery and disposal of the pacemaker.
I also agrae to carr;. th proper id:ntific;;ic.- as
-..,.._.>,.._.....__.,~s
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periodic examinations as rc/ physician has instructed and ::
report any change in my address or tolophone number tc the j
hospital.
=
The risks and possibility of complications have been explained to me and my cuestions concerning this nucic:r pactmaker have been ans.:c.r:d to __ scuinf cticn.
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(to be signed by the patient and two responsible relatives of the patient)
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EXHIB7T VI Proiect 238 I
Instructions to Operator:
1.
Accept any collect call with reference to " Project 23S" 2.
1 Any call concerning " Project 233" involves a patient 'eith a nuclear pacema,.<er and requires immediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacemaker.
3.
Obtain as much information from the caller as is possible including:
Caller's Name and Where he 7.2y be Reached.
Paticnt's Nama, Status, and Xhere he may ne Rcached.
Attending Physician t'if any) and Where ha mall h a Re a c'c.2 d.
(Information from Patient
.3.
C e.rd )
Patient's social Security Number Date of Implant Pacemaker Serial Number 4.
Notify immediately:
(Name, address, telephone nutber of physician responsible for study)
If he cannot be reached, notifv.:
(alternative chvsician)
If neither can be reached, contact physician on dnty for the Cardiac Care Unit; inform him that this involves a nuclear pacemaker; and advisa him of the information you hava and the urgency of the matter.
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v EXHIDIT VII
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The Donor Card will be a wallet-sized card as follows:
(Front; DONOR CARD OF i
Print or type nato o; donor i
In considefation for the implantation in me of an isotopic pace-maker, I hereby.make this irrevccable gift of the pacemaker sys:cm and surrounding tissue to take effect upon my death; I als; give the following other organ; or par s of my nody to take effece upon my death:
(a) any needed organs or parts (b) only the follc..ing organs or parts Specify the organts) or part(s)
TO lioupital (Back)
(c::ccute two copies)
Signed by tae donor and the follc.cing two witnesses in the presence of cach c har:
Signature of Doncr Date of Birth of Dcncr Data Signcu City.cna State Donor is of sound mind and 18 years of age or more:
Witness Witness This is a legal document under the Uniform Anatomical Gift Act, Testamentary or similar laws.
In the event of accidental death or if deatP if immincnt, picaca call:
(Emergency Telephone Kumher) and Natify Cperator "irajac;
'38"*
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(Name of Dcctor)
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U (The folloging is a suggested format for submitting an application for license by letter under the hospital's or institution's letterhead.)
Chief of Materials Branch Division of Materials Licensing Atomic Energy Commission Washington, D.C.
20545 Attention:
James C. Malaro Re:
Application for License.to Implant MedtronicTMLaurens-Alcatel Model 9000 Isotopic Pulse Generator Gentlemen:
The folicwing inforration is submitted in applicaticn for a license to implant the Modtronicl,^iturens-Alcatel Model 9000:
1.
Applicant:
(Eospiual or Institution) 2.
Physician Responsible for Study:
Jaca:
Office Address:
Telephone Number:
State Licensed to Practice In:
Medical School Affiliation:
Specialty Board Certification:
Position ;ith Applicant:
Previous experience in the clinical use of implantable pacemakers by physician:
(include-total nurber of implants physician has done, the total nunter he had done at applicant's facilitias, and a breakdown of how many of these were implancs using myocardial leads) 3.
Other physicians and surgeons participating in study:
(provide scr.e information as above for eac'.1)
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4.
Protccol to be followed:
ModtronicTMLaurens-Alcatel Model 9000 Isotopic Pulse Generator Protoccl dated March 13, 1973.
Modifications to Protocol:
(insert any modifications s tudy team desires to make in Medtronic's Protocol)
TM 5.
Number of Medtronic Laurens-Alcatel Mcdel 9000 requestod to.be implanted annually during study:
6.
Description of physical facilitics and equipment at applicant:
(describe cardiac care unit, operating facilitics and each ~ piece of equipment needed and available to carry out study)
-7.
Descriptic.: of J.pplicant's prcsont pacemaker implantation and Zollow-up progran:
(include size, duration and types of implantations)
The physician ' responsible for the study represents tha't he is familiar with Modtronic's Protocol and ' Technical Manual for tha s.
.;cd trcn: c "-La u r anu-J.lca tel :odel OC00 and understands zh t the issuance of a license is conditioned upon the use of this Protccci and is conditicaed cn tha following of the instructions in the Technical Manual regarding " Transporting, Handling and Ste-4li"' tion of the Pulse Generator", and "Cc=ments on Implantation Procedurc (myccardial 1 cads) ".
Applicant will establish appropriate control proceduros to insure that.the pulse generators are not lost or stolen.
These procedures will include keeping _ track by serial number of the location of each pulse generator and requiring that they be kept under lock when not being used.
Applicant represents that it has adequate fire protec-tion equipnant in caso cf cmcrgcncy and diat all actis _ tics will b a conducted in accordance with :he regulations under 10 cod 2 of Eederal Regulations, Part 70.
The i.pplicant agrees to continue the follow-up, reporting anc recovery procedures required under Mcdtronie's Protocol in the event the Physician Rosponsible for the Study or any other physician or surgeon carticioating in t.ne stuc,y is no,onger associated with Applicant.
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Applicant hereby the :- edtronic., license to receive, requests a nossoas, store m~
and implant laurcas-Alcatel ::odel 9000 Isotopic Pulse Generator in accordance with this application.
Signed:
Aoplicant:
by Its (insert title)
P,n.vsician ec s.uonsible _or s, cuuv:
(letter s'..ould ba signcd
-/ both an officer cr Applicant anc the
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