BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2791781 · Received October 15, 2012

    Report

    Report Number
    3007566237-2012-02458
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD "EXTENSION COMING OUT OF LEFT SIDE". THE PATIENT WAS UNDERGOING STAGE 1 TRIAL FOR FECAL INCONTINENCE AND THEY WERE "SUPPOSED TO HAVE STAGE 2 TOMORROW". IT WAS ALSO REPORTED THE PATIENT EXPERIENCED "VERY SEVERE" NEUROLOGICAL SYMPTOMS. THE MOVEMENT DISORDER SYMPTOMS THAT WERE PRESENT AFTER STAGE 1 INCLUDE "SEVERE TREMOR, LOST BALANCE, CAN'T WALK, CAN'T PUT ON SHOES". PATIENT'S STIMULATION WAS TURNED OFF TODAY. THE SYMPTOMS HAD BEEN PRESENT FOR 1 WEEK. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE WAS NOT DEVICE RELATED. IT WAS STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH METABOLIC ISSUES. AFTER THOSE ISSUES WERE UNDER CONTROL, THE PATIENT WENT ON TO IMPLANT AND WAS RECEIVING EFFECTIVE THERAPY. IT WAS FURTHER CLARIFIED THAT THE "NORMAL LEAD WIRES" WERE CONNECTED TO THE TRIAL BOX ON THE LEFT SIDE. IT WAS NOTED THAT THE "TRUE EXTENSION" WAS NOT COMING OUT OF THE BODY IN A DEFECTIVE WAY AND THAT NO DEVICE RELATED PROBLEM EXISTED. NO FURTHER INFORMATION WAS REPORTED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Other