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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 48593 | 30 October 2012 06:00:00 | Agreement State | Medical Event Involving Permanent Prostate Brachytherapy Implant | The following was received from the Commonwealth of Kentucky via email: During a prostate implant the radiation oncologist and urologist encountered issues due to the prostate size, location and pubic arch. Some of the needles became bent during the procedure and the decision was made to abort the implant. While completing the procedure the radiation oncologist revised the written directive to reflect what had occurred and revised the prescribed dose based on the complications. The patient received 64.51% of the intended dose. The procedure used 14 seeds manufactured by IsoAid with an activity of 0.350 mCi of I-125. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 47980 | 4 June 2009 05:00:00 | Agreement State | Agreement State Report - Three Medical Events Discovered During an Inspection | The following report was received via e-mail: During a routine inspection, three unreported (prostate brachytherapy) medical events were identified. Case One: Implant Date: 6/4/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 69.71% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 69 Case Two: Implant Date: 6/19/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 62.77% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 80 Case Three: Implant Date: 10/29/2009 Prescribed dose: 145Gy to the prostate Post implant CT dosimetry: V100 (the volume of the prostate receiving 100% of the prescribed dose) totaled 65.34% Source: I-125 encapsulated seeds Vendor: IsoAid Model Number: IAI-125A Activity per seed: 0.330 mCi Number of seeds implanted: 84
D90 is defined as minimum dose received by 90% of CT-defined prostate volume Case 1 D90 = 72.80% of 145Gy Case 2 D90 = 58.86% of 145Gy Case 3 D90 = 54.00% of 145Gy Notified R1DO (Cahill) and FSME Events via email. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |