BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3212563 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09319
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 25, 2013
    Report Date
    January 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    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. 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 PATIENT'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCK IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS IN A BLOOD DRAW LAB AROUND LARGE EQUIPMENT DURING THE TIME OF THE OUT OF RANGE MEASUREMENT, SO IT WAS LIKELY THE RESULT OF ELECTROMAGNETIC INTERFERENCE (EMI) WHICH THE PHYSICIAN AGREED WITH. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO CHANGES TO THE SYSTEM HAVE BEEN MADE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AND THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED FROM A FUNERAL HOME OVER SIX YEARS LATER WITH NO FURTHER ALLEGATIONS. THE DEVICE UNDERWENT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313436 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LWP BOSTON SCIENTIFIC CORPORATION E110 155341

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR E110| 1861| 0148| 4087| T125