BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2231893 · Received September 1, 2011

    Report

    Report Number
    2124215-2011-15045
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS OF THE LEAD WAS PERFORMED. THREE SEGMENTS OF THE LEAD WERE RETURNED, INCLUDING A 12 CM PORTION OF THE IS-1 TERMINAL LEG, A 10 CM PORTION OF THE PROXIMAL HIGH VOLTAGE TERMINAL LEG, AND A SEGMENT WITH THE DISTAL HIGH VOLTAGE TERMINAL LEG, THE YOKE, AND 36 CM OF THE MIDDLE OF THE LEAD. THE TIP OF THE LEAD WAS NOT RETURNED. INSPECTION OF THE LEAD SEGMENTS NOTED THEY HAD BEEN SEVERED. BLOOD AND BODY FLUID WERE NOTED ON THE TERMINAL PINS, AND INDUCED DAMAGE WAS NOTED ON SEVERAL PARTS OF THE LEAD. INSPECTION OF THE TERMINAL PINS NOTED SETSCREW MARKS CONSISTENT WITH PROPER LEAD CONNECTION. ELECTRICAL TESTS WERE PERFORMED AND ALL THE RETURNED SEGMENTS WERE FOUND TO BE ELECTRICALLY CONTINUOUS. REVIEW OF THE RELATED DEVICE MEMORY FOUND DAILY IMPEDANCE MEASUREMENTS WERE STABLE AND IN RANGE. ANALYSIS OF THE RETURNED SEGMENTS OF THE LEAD COULD NOT REPRODUCE THE REPORTED CLINICAL OBSERVATION OF NOISE AND THE HIGH SHOCK IMPEDANCE OBSERVED IN THE RELATED DEVICE MEMORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEAD HAD DIED. DIFFICULTY WAS ENCOUNTERED REVIEWING STORED EPISODES AFTER THE DEVICE WAS EXPLANTED. THE RELATED DEVICE WAS RETURNED FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, EPISODES WERE SUCCESSFULLY RETRIEVED. REVIEW OF ELECTROGRAMS (EGMS) NOTED THE DEVICE HAD OVERSENSED NOISE, LEADING TO PACING INHIBITION WITH PERIODS OF VENTRICULAR ASYSTOLE FOR THREE TO FIVE SECONDS. REVIEW ALSO NOTED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. FURTHER INFORMATION WAS RECEIVED THAT THE DATE OF DEATH WAS SUSPECTED TO BE THE SAME DAY AS THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AND OVERSENSING. THE PHYSICIAN STATED THE PATIENT DEATH WAS NOT RELATED TO THE NOISE EPISODES. A PORTION OF THE LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4244| 1861| 0154