BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1853252 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14636
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 22, 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 RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE DID NOT PASS THERAPY AVAILABILITY TESTING. EXAMINATION OF THE DEVICE MEMORY REVEALED THAT THE DEVICE HAD SHOCKED INTO A SHORTED LEAD CONDITION ON (B)(6) 2009. ANALYSIS CONFIRMED THAT THE THIS CONDITION OCCURRED WHILE THE DEVICE WAS STILL IMPLANTED, WHICH RESULTED IN THE DEVICE SUSTAINING INDUCED HIGH ENERGY OVERSTRESS DAMAGE TO THE "U100" HIGH POWER OUTPUT MODULE. THEREFORE, THERAPY WAS NOT ABLE PRIOR TO EXPLANT OF THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ELECTIVELY REPLACED DURING A LEAD REVISION PROCEDURE. THERE WERE NO FIELD ALLEGATIONS REPORTED AGAINST THIS PRODUCT. THIS REPORT WAS CREATED DUE TO LABORATORY FINDINGS.

    Description of Event or Problem · 1

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    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 70 YR