BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3223492 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10469
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 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 NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION INDICATED THAT ALL OTHER MEASUREMENTS WERE NORMAL AND THAT NO INTERVENTION WAS PLANNED AT THIS TIME. THE PHYSICIAN WAS GOING TO CONTINUE MONITORING THE PATIENT THROUGH THE REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321615 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1