BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1864210 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16180
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE BATTERY STATUS WAS AT END OF LIFE (EOL) WITH A BATTERY VOLTAGE OF 2.21 VOLTS. 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. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO A COMPROMISED LOW VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. UPON RETURN, INITIAL ROUTINE DEVICE ANALYSIS REVEALED THE DEVICE HAD FAILED TO MEET LONGEVITY SPECIFICATIONS. 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 T165

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 0175| T165| E110| 4096