BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 861470 · Received June 4, 2007

    Report

    Report Number
    2124215-2007-99611
    Event Type
    Other
    Date Received
    June 4, 2007
    Date of Event
    May 7, 2002
    Report Date
    May 31, 2007
    Product Code
    LWS
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THERE IS NO ADD'L INFO RELATED TO THIS EVENT, IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED. IN 2005 GUIDANT CORPORATION (NOW BOSTON SCIENTIFIC CRM) ISSUED A PHYSICIAN COMMUNICATION REGARDING DETERIORATION IN A WIRE INSULATOR WITHIN THE LEAD CONNECTOR BLOCK WHICH, IN CONJUNCTION WITH OTHER FACTORS, COULD RESULT IN A ELECTRICAL SHORT CIRCUIT THAT CAN PREVENT THE DELIVERY OF SHOCK AND PACING THERAPY. CHANGES TO TRY TO PREVENT THIS ANOMALY WERE MADE IN 2002. THIS DEVICE WAS MANUFACTURED BEFORE APRIL, 2002, AND IS INCLUDED IN THIS POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT WITH THIS DEVICE PASSED AWAY. BOSTON SCIENTIFIC CRM HAS NO SPECIFIC INFO AS TO ANY DEVICE INVOLVEMENT IN THE PT'S DEATH. NEW INFO RECEIVED INDICATES THAT THE PT'S FAMILY HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATION AGAINST THE FUNCTIONALITY OF THE DEVICE WITHIN THE CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death