BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2042460 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01281
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION SUGGESTS THIS DEVICE REMAINS IN-SERVICE. INVESTIGATION IS COMPLETE TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DECLARED THE ELECTIVE REPLACEMENT INDICATOR. THIS DEVICE HAD A REPORTED BATTERY VOLTAGE OF 2.58 AND CHARGES TIMES OF 21 SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. EXPLANT TIMEFRAME WAS DISCUSSED.

    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 78 YR Required Intervention T165| 4472| 0184