BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 4132219 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-16983
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE FAILED LONGEVITY CALCULATIONS AFTER THE DEVICE WAS EXPLANTED 93.1 MONTHS OF IMPLANT DUE TO NORMAL BATTERY DEPLETION. THE BATTERY DEPLETION WAS DUE TO COMPROMISED LOW VOLTAGE CAPACITORS WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THIS PRODUCT DID NOT MEET LONGEVITY EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613095 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 0185| T167| 4470| E163