BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2834209 · Received November 15, 2012

    Report

    Report Number
    3007566237-2012-02729
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND HIS PROGRAMMER DISPLAYED A 'CALL YOUR DOCTOR' ICON. THE PATIENT DID NOT WRITE DOWN THE CODES AND STATED IT HAD BEEN HAPPENING FOR THE TWO DAYS PRIOR TO THE REPORT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE ERROR CODE WAS FROM ENCOUNTERING ELECTROMAGNETIC INTERFERENCE (EMI). THE PATIENT STATED IT HAD NEVER HAPPENED BEFORE AND THE POWER ON RESET (POR) ERROR WAS CLEARED. X-RAYS WERE TAKEN TO CHECK THE LEADS. EVERYTHING LOOKED FINE AND THE STIMULATION WAS WORKING AS IT HAD BEFORE THE INCIDENT. NO FURTHER ACTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1