BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 3905705 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11997
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE INTERROGATION WHEN THE PATIENT WAS IN THE EMERGENCY ROOM, IT WAS NOTED THAT THE DEVICE WAS IN STORAGE MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPLACEMENT OF THE DEVICE. IT WAS NOTED THAT THE PATIENT HAD AN UNDERLYING RHYTHM OF 35 BPM AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384592 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR T125| 0158| 4136