BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2042487 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01131
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    May 1, 2024
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEFIBRILLATOR REACHED ELECTIVE REPLACEMENT INDICATORS (ERI). A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED. THERE WAS CONCERN THAT THE BATTERY HAD DEPLETED MORE RAPIDLY THAN EXPECTED. THIS DEVICE WILL BE RETURNED FOR ANALYSIS. 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 T175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown