BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 4037501 · Received August 21, 2014

    Report

    Report Number
    MW5037888
    Event Type
    Other
    Date Received
    August 21, 2014
    Date of Event
    April 2, 2014
    Report Date
    August 13, 2014
    Product Code
    NVZ
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC IMPLANTED DEVICE 4076 AND 4198 REPLACED ON (B)(6) 2014 AT (B)(6) HOSPITAL, (B)(6). I WAS TAKEN BY AMBULANCE BECAUSE THE DEVICE SHOCKED ME TWICE AT HOME AND ONCE AT THE HOSPITAL EMERGENCY ROOM. ADVISED BY DOCTOR TO GO BY AMBULANCE TO HOSPITAL. THIS IS THE SECOND TIME I HAVE HAD THIS DEVICE REPLACED. ON DECEMBER 20, 2010, BATTERY DIED, REPLACED DEVICE. KNOW OTHERS WHO HAVE DIFFERENT DEVICES WITH NO PROBLEMS. WHEN I ARRIVED IN THE HOSPITAL EMERGENCY ROOM, I WAS TOLD THAT THERE ARE THREE TECHNICAL PEOPLE FROM MEDTRONIC TO TURN OFF DEVICES. THIS IS A PROBLEM! I FEEL THAT THIS IS A DEFECTIVE PRODUCT AND NO ONE CARES TO HELP THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505734 MEDTRONIC NONE NVZ 4076-52
    505735 MEDTRONIC NONE DTB 4194-88

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR