BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM 2DR

    MDR report key: 861483 · Received June 4, 2007

    Report

    Report Number
    2124215-2007-99599
    Event Type
    Death
    Date Received
    June 4, 2007
    Date of Event
    October 19, 2006
    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 ADDITIONAL INFORMATION RELATED TO THIS EVENT, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED. ON JUNE 17, 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 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 MANUFACTURED BEFORE APRIL, 2002, AND IS INCLUDED IN THIS POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED 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. THE PATIENT'S FAMILY HAS RETAINED LEGAL COUNSEL AND FILED A LAWSUIT. THERE WERE NO SPECIFIC ALLEGATIONS WITHIN THE LEGAL CLAIM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 4064| 0148