BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 913100 · Received September 14, 2007

    Report

    Report Number
    2124215-2007-99721
    Event Type
    Death
    Date Received
    September 14, 2007
    Date of Event
    April 18, 2006
    Report Date
    September 13, 2007
    Product Code
    LWS
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF TODAY THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IT MAY HAVE BEEN BURIED WITH THE PATIENT. IF THE DEVICE IS RETURNED THE EVENT WILL BE UPDATED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE THE EVENT WILL BE UPDATED. ON JUNE 17, 2005 GUIDANT CORP (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 AN ELECTRICAL SHORT CIRCUIT THAT CAN PREVENT THE DELIVERY OF SHOCK AND PACING THERAPY. CHANGES TO TRY TO PREVENT THIS ANOMALY WERE MADE IN APRIL AND NOVEMBER OF 2002. THIS DEVICE WAS MFG BEFORE APRIL 2002, AND IS INCLUDED IN THIS POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED DUE TO UNSPECIFIED CAUSE. AT THE TIME OF THE PATIENT'S DEATH, THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS. NEW INFORMATION INDICATES THAT THIS PATIENT OR A REP FOR THE PATIENT HAS RETAINED AN ATTORNEY AND RECENTLY SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS.

    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