BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2170934 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09904
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WENT TO THE EMERGENCY ROOM (ER) COMPLAINING OF RECEIVING SHOCKS. UPON DEVICE INTERROGATION IT WAS NOTED THAT 4 SHOCKS WERE NEEDED TO CONVERT THE PATIENTS ARRHYTHMIA. THE PATIENT WENT HOME AND THEN RETURNED TO THE ER THE NEXT MORNING STATING HE HAD RECEIVED MORE SHOCKS. ANOTHER INTERROGATION WAS DONE WHICH SHOWED AN OVERSENSED EPISODE OVERNIGHT, WHICH INHIBITED PACING FOR SEVERAL SECONDS, HOWEVER SINCE THE PATIENT HAS THEIR OWN STRONG INTRINSIC, NO SYMPTOMS WERE NOTED.

    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 72 YR 1823| 4470| 4543| H210| 0154| 4512