BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4140017 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17070
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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 ATRIAL (RA) LEAD EXHIBITED INTERMITTENT HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS AT FOLLOW UP. IT WAS ALSO NOTED THAT NOISE WAS PRESENT ON SOME ELECTROGRAMS (EGMS) WHICH THE ICD MARKED AS ATRIAL FIBRILLATION (AF) IN ADDITION TO SOME PACING AT THE MAXIMUM TRACKING RATE OF 110 PPM. LEAD FRACTURE WAS SUSPECTED BY THE PHYSICIAN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND AGREED THAT THE NOISE PRESENT ON SOME EGMS WAS CONSISTENT WITH A LEAD FRACTURE. DEVICE SENSITIVITY WAS REPROGRAMMED AND THE PHYSICIAN DOES NOT PLAN ON TAKING FURTHER ACTION UNTIL UNTIL THE PATIENT'S NEXT FOLLOW UP IN SEVERAL MONTHS. THE PATIENT IS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620248 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 4096| F110| 0185