BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1946168 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20111
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING DETAILED LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND WAS REPLACED WITH A COMPETITIVE DEVICE. THE EXPLANTED DEVICE WAS RECEIVED BY THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE FOR RETURN. UPON RECEIPT, INITIAL LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY PREDICTIONS AS DESCRIBED IN DEVICE LABELING. THERE WERE NO ALLEGATIONS AGAINST THIS DEVICE WHILE IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4470| T127| 6949