BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1952578 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23572
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS HAVE STEADILY INCREASED, EVENTUALLY MEASURING GREATER THAN 2,000 OHMS. ADDITIONALLY, THRESHOLD MEASUREMENTS HAVE INCREASED, ALONG WITH OVERSENSING. THE NON-PACER DEPENDENT PATIENT WAS REPORTEDLY PACING 10% IN THE RV. ISOMETRICS RECREATED RANDOM UNDERSENSING. TECHNICAL SERVICES RECOMMENDED FURTHER EVALUATION OF THE RV LEAD. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    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 67 YR T125| 1600| 4244| E110| 6945| 4312| 0041| 1625| 1821