BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3043186 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03334
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 15, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    DEVICE AND LEAD REMAIN IMPLANTED. 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

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES 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. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. 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.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED DURING THE LAST CLINIC VISIT FOR LEAD EVALUATION. THE SHOCK IMPEDANCES WERE WITHIN NORMAL RANGE. THE DEVICE WAS LEFT WITH THE PREVIOUS PROGRAMMING. THERE WAS NO ROOT CAUSE FOUND FOR THE OUT OF RANGE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE DETECTED THROUGH REMOTE MONITORING SYSTEM ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN FOLLOWING THE SECOND OUT OF RANGE MEASUREMENT FOR EVALUATION. MANUAL TESTS IN CLINIC WERE PERFORMED SHOWING THE OUT OF RANGE MEASUREMENTS WERE FOUND IN VARIOUS PROGRAMMING CONFIGURATIONS. THE MEASUREMENTS WERE NOTED TO BE A GRADUAL RISE SINCE IMPLANT. THE LOCAL FIELD REPRESENTATIVE DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO PERFORM COMMAND SHOCKS OF 1.1J AND MAX ENERGY TO GET IMPEDANCE OF DELIVERED ENERGY FOR A TRUE TEST OF THE SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS. A REQUEST FOR STATUS OF THE LEAD WAS SENT.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145006 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R A155| E110| 4086