BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3904311 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09708
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. IMPEDANCES WERE NOTED TO HAVE INCREASED OVER THE COURSE OF APPROXIMATELY 1 YEAR FROM 1,550 OHMS TO GREATER THAN 2,000 OHMS AT THE TIME OF REPORT. ALL OTHER ELECTRICAL PARAMETERS WERE STABLE AND WITHIN NORMAL LIMITS. PROVOCATION TESTING WAS PERFORMED AND NOISE WAS NOT OBSERVED ON THE LEAD. IT WAS NOTED THAT THE PATIENT IS NOT PACEMAKER DEPENDENT AND WILL PRESENT FOR FREQUENT FOLLOW UP. NO SIGNS OF LEAD DAMAGE WERE VISIBLE ON X-RAY AND NO REVISION WILL TAKE PLACE AS LONG AS NO FURTHER ELECTRICAL ISSUES ARISE WITH THE LEAD. THE CAUSE OF THE HIGH OUT OF RANGE MEASUREMENTS WAS NOT DETERMINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385103 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 F110| 5554| 0175