BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 711910 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-14526
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    March 30, 2006
    Report Date
    March 30, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS UNDERGOING NEUTRON RADIATION THEARPY. INTERROGATION AFTER TREATEMENT REVEALED THE DEVICE HAD REVERTED TO SAFETY MODE. A GUIDANT TECHNICAL SERVICES CONSULTANT EXPLAINED SAFETY MODE FUNCTION AND RECOMMENDED THAT THE DEVICE CONTINUE TO BE CHECKED AFTER EACH SUBSEQUENT RADIATION TREATMENT, SO THAT THERAPY AVAILABLITY CAN BE CONFIRMED. PACING WAS VERIFIED. WHEN RADIATION TREATMENTS ARE COMPLETE, REPLACEMENT IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other