BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2780933 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13217
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 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 THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT RECEIVED A SHOCK FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) AND THE PATIENT CAME IN FOR A SYSTEM EVALUATION. A REVIEW OF THE STRIP CONFIRMED THAT DUE TO HOW THE DEVICE HAD BEEN PROGRAMMED THE THERAPY DELIVERY WAS NORMAL FUNCTION. DURING THE EVALUATION, IT WAS REVEALED THAT THE DEVICE HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) FOUR MONTHS AGO. TODAY, THE BATTERY VOLTAGE IS 2.24V AND THE CHARGE TIME IS 26.9 SECONDS. THE CALLER DOES NOT KNOW WHY THIS PATIENT HAD NOT BEEN SCHEDULED FOR A DEVICE REPLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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
    1 308 MO T177| 0180