BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173878 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10638
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE. A REVIEW OF THE DEVICE INFORMATION NOTED NO ARRYTHMIAS AND ALL MEASUREMENTS WERE APPROPRIATE. IT WAS NOTED THAT TWO DAYS OF DAILY MEASUREMENTS WERE NR. IT WAS EXPLAINED THAT DAILY MEASUREMENTS ARE THE LOWEST PRIORITY OF THE DEVICE AND ARE NOT RESCHEDULED IF PRE-EMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening (B)(4)| (B)(4)