BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3043591 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02490
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND UNKNOWN RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145138 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1