BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 4172356 · Received October 15, 2014

    Report

    Report Number
    3007566237-2014-02988
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 23, 2014
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRIAL LEAD SHIFTED DURING THE TRIAL AND THE MANUFACTURER¿S REPRESENTATIVE (REP) HAD TO HAVE THE PATIENT SWITCH TO ANOTHER GROUP. IT SEEMED LIKE AN INCONVENIENCE FOR THE PATIENT TO HAVE TO SWITCH THE GROUPS SO THE REP. THOUGHT A PRIMARY CELL BATTERY WOULD WORK BEST. LONGEVITY CALCULATIONS WERE REQUESTED BASED ON VARIOUS SETTINGS. ADDITIONAL INFORMATION RECEIVED FROM THE REP. STATED THAT IT WAS UNCLEAR IF THE LEAD MOVED. AFTER THE PATIENT SWITCHED TO GROUP B ON (B)(6) 2014 THE PATIENT STATED HE FELT THE STIMULATION COVERED HIS AREA OF PAIN MORE. AFTER FURTHER DISCUSSION WITH THE PATIENT IT WAS UNCLEAR WHETHER HE HAD THE INITIAL GROUP UP STRONG ENOUGH TO TELL WHETHER OR NOT THE STIMULATION WAS COVERING HIS AREA OF PAIN. AFTER THE PATIENT DID SOME PHYSICAL ACTIVITY HE SAID HE HAD AT LEAST 70% RELIEF, AND THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE PATIENT WAS MOVING FORWARD WITH A PERMANENT IMPLANT DUE TO A SUCCESSFUL TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653606 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1