BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3760911 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08847
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    July 28, 2012
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    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 THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE RV PACING IMPEDANCES GREATER THAN 2,000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS SEEN IN CLINIC AND A FULL EVALUATION WAS PERFORMED OF THE PATIENT'S SYSTEM. THE RV LEAD IMPEDANCES VARIED FROM 1,989 TO GREATER THAN 2,000 OHMS. IT WAS NOTED THAT MOST MEASUREMENTS WERE LESS THAN 2,000 OHMS AND THRESHOLD AND SENSING MEASUREMENTS WERE FOUND TO BE STABLE, AND THERE WAS NO NOISE FOUND ON THE INTRACARDIAC ELECTROGRAMS. IT WAS ADDITIONALLY NOTED THAT THE PATIENT DOES NOT SIGNIFICANTLY PACE IN THE VENTRICLE AND HAS NORMAL SINUS RHYTHM FOR AN UNDERLYING RHYTHM, THUS THE PHYSICIAN WAS COMFORTABLE WITH CONTINUED MONITORING OF THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239382 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR E110| T165| 4470| 0185