BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3781149 · Received April 30, 2014

    Report

    Report Number
    3007566237-2014-01194
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SMALL FIBER NEUROPATHY IN THEIR FEET. IT WAS FURTHER REPORTED THAT DURING THE TRIAL THE PATIENT HAD THEIR DEVICE ADJUSTED TO ISOLATE THE BLOCKAGE JUST ABOVE THE PATIENT¿S ANKLES SO THAT STIMULATION WAS DOWN AT THE PATIENT¿S FEET. IT WAS FURTHER REPORTED THAT DURING THE TRIAL ONE OF THE PROBES MOVED UP ON THE SPINE ABOUT A HALF INCH OR MORE (FROM T9-T10). IT WAS THEN NOTED THAT THIS WAS CORRECTED AS WAS ¿NOT RIGHT.¿ IT WAS UNCLEAR WHAT WAS MEANT BY THIS. IT WAS NOTED THAT A MANUFACTURER REPRESENTATIVE CAME IN THE NEXT DAY AND WAS ABLE TO ADJUST THE STIMULATION FROM THIGH CALF DOWN TO PATIENT¿S FEET. IT WAS LATER REPORTED THAT THE TRAIL WAS ¿ALL BOTCHED UP¿ AND THAT THE LEADS MOVED ON THE 1ST DAY. IT WAS NOTED THAT THEY READJUSTED THE LEADS GETTING 50% TO 60 % AND THE PATIENT GOT SOME RELIEF IN THEIR FEET. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS AWARE OF THE TRIAL LEAD MIGRATION AT THE TIME OF ADJUSTMENT BECAUSE AN X-RAY HAD BEEN TAKEN. THE LEAD WAS REPORTEDLY REPROGRAMMED AND THE PATIENT COMPLETED THE TRIAL SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT DURING THE TRIAL IS WHEN "THE PROBLEMS BEGAN." THE PATIENT STATED THAT THE "CABLES" WEREN'T PUT IN EXACTLY RIGHT, ONE WAS HIGHER THAN THE OTHER. A COMPANY REPRESENTATIVE WAS ABLE TO GET SOME STIMULATION TO WORK BUT NOT DOWN TO THE PATIENTS FEET. THE PATIENT STATED THAT THE PHYSICIAN WOULD ONLY ALLOW FOR A 3 DAY TRIAL, SO THEY MOVED ON TO IMPLANT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259937 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention