BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 734212 · Received July 10, 2006

    Report

    Report Number
    2124215-2006-99452
    Event Type
    Death
    Date Received
    July 10, 2006
    Report Date
    July 7, 2006
    Manufacturer
    CLONMEL
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION: AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO GUIDANT FOR ANALYSIS. THERE IS NO ADDITIONAL INFO RELATED TO THIS EVENT. GUIDANT WILL CONTINUE TO INVESTIGATE THE COMPLAINT, AND IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE REOPENED. ON MAY 12,2006 GUIDANT ISSUED A PHYSICIAN COMMUNICATION REGARDING THE POTENTIAL FOR PREMATURE BATTERY DEPLETION IN A SMALL SUBSET OF ICD AND CRT-D DEVICES. PREMATURE DEPLETION MAY RESULT FROM A FAILURE OF A CAPACITOR FROM A SINGLE LOT. THIS DEVICE IS INCLUDED IN THIS ADVISORY POPULATION; HOWEVER, GUIDANT HAS NOT REC'D THE DEVICE NOR CONFIRMED ANY DEVICE ABNORMALITY.

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT REC'D INFORMATION THAT THE PT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXPIRED APPROXIMATELY TWO MONTHS AFTER THE IMPLANTATION OF THIS DEVICE. THE IMPLANT DATE COULD NOT BE OBTAINED. THERE WERE NO SPECIFIC ALLEGATIONS OR COMPLAINTS AGAINST THE DEIVCE. THE DEVICE WAS EXPLANTED, BUT HAS NOT BEEN RETURNED TO GUIDANT FOR ANALYSIS. ATTEMPTS TO OBTAIN ADD'L INFO ABOUT THIS REPORTED DEATH WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CLONMEL T165 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death