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Start date | Reporting criterion | Title | Event description | System | LER | |
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ENS 40088 | 18 August 2003 16:00:00 | Agreement State | Patient Exceeded Prescribed Dose. | A patient was undergoing an intravascular brachytherapy procedure using a Novoste 40 mm. Sr-90 system with a prescribed dose of 23 gray. Due to difficulties retracting the source train to its shielded position, the exposure time was 5.09 minutes (one minute longer than the planned 4.09 minutes). Preliminary estimates indicate that the delivered dose exceeded the prescribed dose by approximately 25 percent. Novoste was notified and a Novoste representative went to the medical facility to investigate. The Novoste system will be sent to Novoste in Georgia for analysis. The licensee continues to investigate and refine the dose calculations and will submit the required written report as soon as possible. Illinois assigned event number: IL030064. |