BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1945550 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19920
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN STORAGE MODE. IT WAS NOTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY 11 MONTHS AGO, AND END OF LIFE (EOL) APPROXIMATELY EIGHT MONTHS AGO. THE PATIENT HAD NOT HAD A DEVICE CHECK IN OVER A YEAR. THE PATIENT NOTED HEARING BEEPING TONES; HOWEVER, THEY THOUGHT IT WAS THEIR WATCH BEEPING. THE CHARGE TIME (CT) WAS NOTED TO BE 40 SECONDS AND THE BATTERY VOLTAGE WAS 2.17. PREMATURE BATTERY DEPLETION WAS ALLEGED. TECHNICAL SERVICES (TS) DISCUSSED REPLACEMENT AND RETURN OF THE DEVICE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention T165| 5076| 0185