BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211646 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09414
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 3, 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

    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

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    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. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED HIGH, OUT OF RANGE SHOCK IMPEDANCES ON THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD. THIS WAS DETECTED THROUGH THE PATIENT'S REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WAS UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE RV LEAD WAS SURGICALLY ABANDONED DUE TO SHOCK IMPEDANCE MEASUREMENTS BETWEEN 105 AND 120 OHMS. IT WAS INDICATED THE PATIENT RECEIVED APPROPRIATE SHOCK THERAPY OFTEN AND THE PHYSICIAN WAS CONCERNED OVER THE IMPEDANCE MEASUREMENTS. THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311174 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 1860| E110| 497-23-60| 4076