BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911324 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15987
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 29, 2012
    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 THIS DEVICE SYSTEM DETECTED AN INCREASED PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS ON A NON-BSC RIGHT VENTRICULAR (RV) LEAD. ALL OTHER LEAD MEASUREMENTS WERE STABLE AND WITHIN ACCEPTABLE LIMITS. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. POCKET MANIPULATION AND ISOMETRIC EXERCISES WERE UNREMARKABLE. IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE SYSTEM REPORTED LESS THAN ONE PERCENT. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19144 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 6947| E102