BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2931571 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00295
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_SILICONEANCHOR, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID NEU_CABLE/SCREEN. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 3487A-28, LOT# 0205795874, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT #0205795874) FOUND THAT THE PROXIMAL END INSULATION WAS BROKEN UNDER THE CONNECTOR. ANALYSIS OF THE CABLE, ANCHOR, AND EXTENSION FOUND NO ANOMALIES. THE LEAD, EXTENSION, AND SCREENING CABLE WERE TESTED TOGETHER WITH A KNOWN GOOD SCREENER. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR. THE OUTER INSULATION ON THE LEAD WAS TORN UNDER THE #0 CONNECTOR SLEEVE. THE WIRE INSULATION WAS STILL GOOD AT THAT LOCATION. RESULT: CABLE SCREENER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAD IMPLANTED AND CONNECTED TO AN EXTERNAL NEUROSTIMULATOR (ENS) FOR A TESTING TRIAL. THE DATE OF IMPLANT WAS UNCLEAR AND WAS REPORTED AS BOTH (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD "PAIN WITH AMPUTATION." IT WAS REPORTED THAT THE ENS WAS TURNED UP TO 10V, BUT THE PATIENT COULDN'T FEEL ANY DIFFERENCE AND HER PAIN WAS NOT RELIEVED. IT WAS REPORTED THAT THE ENS WAS EXCHANGED FOR A DIFFERENT ENS ON (B)(6) 2013 AND TWO OTHER ENSS WERE EXCHANGED FOR TESTING ON (B)(6) 2013, BUT THE PATIENT STILL DIDN'T FEEL ANY DIFFERENCE AND HER PAIN WAS NOT RELIEVED. THE LEAD WAS EXPLANTED. IT WAS NOTED THAT THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT DID NOT HAVE ANY CONTAGIOUS DISEASE. EIGHT DAYS LATER, IT WAS REPORTED THAT THE PATIENT STILL FELT AS MUCH PAIN AS BEFORE AND DID NOT RECEIVE ANY RELIEF. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36948 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention