BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1871193 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18189
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE TWO MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED <20 OHMS SHOCK IMPEDANCE MEASUREMENT, TRIGGERING A LATITUDE RED ALERT. THE PATIENT DID ALSO PRESENT TO THE EMERGENCY ROOM AS A RESULT OF RECEIVING MULTIPLE SHOCKS. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED THAT A SHOCK LEAD IMPEDANCE EVALUATION BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR E110| 0175| 4470