BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY VR

    MDR report key: 626897 · Received August 10, 2005

    Report

    Report Number
    2124215-2005-10429
    Event Type
    Malfunction
    Date Received
    August 10, 2005
    Date of Event
    May 30, 2005
    Report Date
    May 30, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED ON MAY 15, 2003 PRESENTED AT FOLLOW UP WITH THE BATTERY STATUS OF MOL 2. VOLTAGE 2.58 V. CUMULATIVE CHARGE TIME: 16.8 SECONDS. ONLY ONE SHOCK WAS DELIVERED AT THE INDUCTION. THE DEVICE REMAINS IMPLANTED. THERE IS A CONCERN VOICED THAT THE BATTERY IS DEPLETING MORE RAPIDLY THAN ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1870 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other