BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3222459 · Received July 12, 2013

    Report

    Report Number
    3007566237-2013-02324
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT HAD REPORTEDLY TURNED THE EXTERNAL NEUROSTIMULATOR (ENS) OFF PRIOR TO ENTERING A STORE. AFTER ENTERING THE STORE, THE PATIENT TRIED TO TURN THE ENS ON AND RECEIVED A ¿CALL YOUR DOCTOR¿ ICON AND A POWER ON RESET (POR) MESSAGE. IT WAS MENTIONED THAT THE POR MAY HAVE BEEN CAUSED BY ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE STORE SECURITY GATES. THE PATIENT WAS ABLE TO CLEAR THE POR AND TURN STIMULATION BACK ON. THE PATIENT ALSO REPORTED THAT WHEN SHE RODE IN THE CAR, IT FELT LIKE IT ¿JOLTED HER IN THE BACK.¿ IT WAS ALSO REPORTED THAT WHEN STIMULATION WAS INCREASED FOR THE RIGHT LEG, THE PATIENT WAS ABLE TO FEEL STIMULATION IN BOTH LEGS, EVEN WHEN THE LEFT LEG WAS TURNED COMPLETELY OFF. THE PATIENT STATED THAT WHEN SITTING, SHE DID NOT FEEL STIMULATION ON THE OUTER RIGHT LEG, WHICH WAS WHERE IT HURT MOST. IT WAS NOTED THAT THE PATIENT W AS TO MEET WITH THE MANUFACTURING REPRESENTATIVE FOR REPROGRAMMING ON THE DAY FOLLOWING THIS REPORT. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN REPROGRAMMED AND BEEN PROVIDED WITH ADDITIONAL EDUCATION ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT WAS VERY HAPPY WITH THE RESULTS AND HAD A POSITIVE TRIAL. THE PATIENT WAS REPORTEDLY BEING SCHEDULED FOR A PERMANENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322100 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37022

    Patients

    Seq Age Sex Outcome Treatment
    1