BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2052748 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03622
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    December 6, 2007
    Report Date
    March 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF INCREASED SHOCK IMPEDANCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED AN ELEVATED SHOCK IMPEDANCE OF 79 OHMS, EXHIBITED BY THIS PATIENT'S TRANSVENOUS DEFIBRILLATION LEAD. IT WAS NOTED THAT THE PACING IMPEDANCE HAD GONE DOWN, AND THEN LEVELED OUT. THE PATIENT REPORTED FEELING A 'VIBRATION' IN THEIR CHEST AND QUESTIONED IF THIS COULD HAVE BEEN FROM THE DEVICE. A TECHNICAL SERVICES (TS) CONSULTANT SUGGESTED PERFORMING A HIGH ENERGY SHOCK TO TEST THE INTEGRITY OF THE LEAD SYSTEM. TS ALSO DISCUSSED THAT OUR DEVICES DO NOT VIBRATE. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION AT THAT TIME, BUT WAS UNABLE TO PROVIDE ADDITIONAL DETAIL. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND WAS RETURNED FOR ANALYSIS. ROUTINE INITIAL DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR T177| 0185