BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771322 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12436
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DETAILED ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON DETAILED ANALYSIS WE CONFIRMED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT OF 23 SECONDS. TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS NORMAL, OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS SHOWED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE TO DATE AND PROGRAMMED SETTINGS. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY CHARGE TIMES IN EXCESS OF THE 23 SECOND EXTENDED ERI CHARGE TIME LIMIT. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, AN ERI CHARGE TIME REPLACEMENT INDICATOR WAS DECLARED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO ALLEGATIONS. INITIAL ANALYSIS SHOWED THAT THE DEVICE FAILED LABEL LONGEVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1