BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3052621 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03620
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 3, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. TECHNICAL SERVICES (TS) WAS CONTACTED REGARDING THE FLUCTUATING SHOCK IMPEDANCE MEASUREMENTS. TS REVIEWED THE DATA AND CONFIRMED THE MEASUREMENTS HAVE FLUCTUATED BETWEEN 100 -130 OHMS WHICH IS NOT UNCHARACTERISTIC FOR A SINGLE COIL LEAD. IN ADDITION, PACING IMPEDANCE MEASUREMENTS OF THE NON-BOSTON SCIENTIFIC LEAD HAVE INCREASED APPROXIMATELY FIVE HUNDRED OHMS. A NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENT WAS DISPLAYED. APPROPRIATE SENSING IS NOTED AND THERE IS NO NOISE OR ARTIFACT NOTED. TS RECOMMENDED FURTHER MONITORING THIS SYSTEM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND THIS SYSTEM IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. THE PATIENT PRESENTED FOR A FOLLOW UP VISIT AFTER RECEIVING AN INAPPROPRIATE SHOCK DUE TO CONDUCTED ATRIAL FIBRILLATION WHILE EXCERCISING. THE LEAD TREND DISPLAYED INCREASED SHOCK IMPEDANCE MEASUREMENTS SINCE IMPLANT. IT WAS THOUGHT THIS WAS DUE TO THE NON-BSC SINGLE COIL LEAD. SUCCESSFUL DEFIBRILLATION THRESHOLD (DFT) TESTING POST IMPLANT HAD BEEN PERFORMED. NO CHANGES ARE INTENDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156654 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 4471| S601