BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2913367 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00302
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION (PBD) . NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20164 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R