BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1944932 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19575
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    March 26, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT ANOTHER RED ALERT WAS ISSUED IN LATITUDE FOR A SHOCK IMPEDANCE MEASUREMENT OF >125 OHMS. IT WAS NOTED THAT THE PATIENT WAS SEEN IN THE CLINIC THREE DAYS LATER AND THE SHOCK IMPEDANCE WAS 110 OHMS. IN THE PATIENT'S NEXT REMOTE INTERROGATION FOUR DAYS AFTER THE IN OFFICE CHECK, THE SHOCK IMPEDANCE WAS 113 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO CHANGES HAVE BEEN MADE TO THE SYSTEM.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON AND RETURNED FOR TESTING. 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. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE REPORTED THAT THE PATIENT WAS GOING TO BE SEEN IN THE CLINIC TO EVALUATE THE LEAD. IN THE CLINIC, THE SHOCK IMPEDANCE MEASUREMENT WAS 122 OHMS, AND THE PATIENT'S NEXT REMOTE INTERROGATION SHOWED AN IMPEDANCE MEASUREMENT OF 118 OHMS. TECHNICAL SERVICES DISCUSSED TESTING THE SYSTEM WITH A MAXIMUM ENERGY SHOCK. AN OUT OF RANGE IMPEDANCE WOULD INDICATE A BREAK IN CONDUCTION. THE FIELD REPRESENTATIVE LATER REPORTED THAT A COMMANDED SHOCK WAS PERFORMED AND THE IMPEDANCE MEASUREMENT WAS WITHIN NORMAL RANGE. THE PHYSICIAN HAS DECIDED NO FURTHER ACTION WOULD BE TAKEN AT THIS TIME. THE LEAD REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD PRODUCED A SHOCK IMPEDANCE MEASUREMENT OF >125 OHMS. A RED ALERT WAS ISSUED IN LATITUDE FOR THIS OUT OF RANGE MEASUREMENT.

    Description of Event or Problem · 1

    PLEASE AMEND THIS REPORT TO REFLECT THE MODEL SERIAL NUMBER OF THE DEVICE. THIS WAS DETERMINED TO BE A DEVICE ISSUE AND NOT A LEAD ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4136| E110| 0181