BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-05874

    MDR report key: 2151647 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-05874
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 2, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THRESHOLD TESTING WITH RADIOFREQUENCY, AN UNKNOWN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LOST TELEMETRY AND CONTINUED TESTING. TECHNICAL SERVICES (TS) DISCUSSED SINCE TELEMETRY WAS LOST, THE DEVICE DID NOT KNOW TO STOP. IT WAS NOTED THAT THE PATIENT WAS PACER DEPENDANT; HOWEVER, HAD NO ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention