Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a medical/technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The envelope seal was cut.The returned sample as received was found not to meet medtronic quality release specifications after application in the clinical setting, and due to the damaged envelope seal the reported condition was confirmed.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.
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