BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 1864186 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16068
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1107-05,Z-1108-05,Z-11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED LONG CHARGE TIMES DURING MIDDLE OF LIFE AND NOW IS EMITTING BEEP TONES. INTERROGATION CONFIRMED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR A155| 4087| 0185