Section b3: event date is estimated.The allegation is against one of two leads; however, it is unknown which leads, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9061760 it was reported to abbott, a patient underwent an lead revision.Surgery took place where two new leads were added to the existing drg system.There were no complications.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, the cause of the reported issue was determined not to be product related.
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