BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3973164 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02152
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3555-31, SERIAL# UNKNOWN, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3555-31, SERIAL# UNKNOWN, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. IT WAS NOTED THAT SINCE THE PERIPHERAL NERVE STIMULATION LEADS (2X8) WERE PLACED ON THE DAY PRIOR TO THE REPORT FOR THE TRIAL; THE PATIENT HAD NOT HAD STIMULATION SENSATION. IMPEDANCES WERE NOT CHECKED DURING THE PROCEDURE AND THE PATIENT WAS NOT GETTING STIMULATION SENSATION DURING THE PROCEDURE. IT WAS NOTED THE LEADS WERE PERIPHERAL. ON THE DAY OF THE REPORT IT WAS REPORTED THAT THERE WAS NO STIMULATION FELT WHEN STIMULATION WHEN CRANKED UP ALL THE WAY. IT WAS THEN REPORTED THAT IMPEDANCES WERE GREATER THAN 40,000 OHMS ON THE DAY OF THE REPORT. ALL PAIRS WERE REPORTEDLY GREATER THAN 40,000 EXCEPT ELECTRODES 8-14 WITH #8. IT WAS NOTED THAT THOSE ELECTRODES WERE ALL AROUND 5000 OHMS OR LESS. 8-15 PAIR WAS REPORTEDLY AROUND 11,000 OHMS. PAIRS WITH #14 WERE LESS THAT 40,000 BUT WERE GREATER THAN 30,000. IT WAS NOTED THAT THE MULTI-LEAD TRIALING CABLE (MLTC) WAS CHANGED OUT AND THE IMPEDANCES WERE THE SAME. IT WAS NOTED THAT THE OLD MLTC WAS DRY WHEN THE OPENED IT. 8, 9, 10, 11, WERE PROGRAMMED WITH 330 US AND 60HZ BUT NO STIMULATION WAS FELT UP TO 10 VOLTS. IT WAS NOTED THAT THERE WAS NO VISIBLE DAMAGE TO THE LEADS. IT WAS FURTHER NOTED THAT THE DISTAL ELECTRODES WERE COMING OUT OF THE BODY AND THEY COULD SEE THE POSITIONING OF THE OTHER LEAD AND WANTED THE HEALTH CARE PROVIDER (HCP) TO TAKE A LOOK. IT WAS SUSPECTED THAT THE OTHER LEAD MAY HAVE COME OUT AS WELL, GIVEN THE IMPEDANCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451279 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) GZF MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1