BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2052143 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03301
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS SUCCESSFULLY INTERROGATED. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID MEET EXPECTED LONGEVITY. MICROSCOPIC VISUAL INSPECTION IDENTIFIED MARKS ON THE CASING FROM THE EXPLANT PROCEDURE. THE DEVICE WAS PUT THROUGH AND FAILED A PORTION OF DIAGNOSTIC TESTING THAT ASSESSES THE THERAPY AVAILABILITY OF THE DEVICE. THE STORED MEMORY WAS REVIEWED AND THE DEVICE EXHIBITED NORMAL CHARGE TIMES PRIOR TO EXPLANT. THE DEVICE PERFORMED AN AUTOMATIC CAPACITOR REFORMATION IN (B)(6) 2010 (POST-EXPLANT). ALTHOUGH A CHARGE TIME-OUT OCCURRED DUE TO HIGH CELL IMPEDANCE, FURTHER REVIEW OF THE MEMORY LOG DETERMINED THAT NO COMPONENT FAILURE WAS PRESENT AT THAT TIME. SUBSEQUENTLY, EXTENSIVE LABORATORY TESTING FOUND THAT A DEVICE TRANSFORMER HAD BEEN DAMAGED. IT WAS CONCLUDED THAT THE FAILED THERAPY AVAILABILITY TEST WAS THE RESULT OF INDUCED DAMAGE THAT OCCURRED POST-EXPLANT PRIOR TO ARRIVAL AT BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT FOR LABORATORY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR T175| 0186| E102