BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3043324 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01982
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    September 29, 2012
    Report Date
    December 2, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS EXPLANTED AND REPLACED APPROXIMATELY SIX MONTHS LATER. AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IMPLANTED AND 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.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED THAT TACHYCARDIA THERAPY WAS PROGRAMMED OFF IN THE DEVICE PENDING A REVISION PROCEDURE. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. A PHYSICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND REPORTED THAT THE LEAD ALSO EXHIBITED NON-PHYSIOLOGIC NOISE THAT RESULTED IN TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS LATER EXPLANTED AND RETURNED 5 YEARS LATER FOR UNRELATED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145595 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR E102| 1860| 0138