BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3851552 · Received June 5, 2014

    Report

    Report Number
    3007566237-2014-01540
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    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

    ANALYSIS OF THE LEADS (LOT NO. VA0HQ7C010, LOT NO. VA0JCUC036) FOUND NO ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_CABLE/SNAPLID, SERIAL# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_CABLE/SNAPLID, SERIAL# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    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 DURING A TRIAL LEAD PLACEMENT PROCEDURE ON (B)(6) 2014, ONE OF THE LEADS HAD HIGH IMPEDANCES, BUT IT EVENTUALLY CAME DOWN AND THE PATIENT GOT INTRAOPERATIVE COVERAGE. IT WAS NOTED THE RIGHT SIDE MAINTAINED IN THE 5000-7000 RANGE, AND THE PATIENT STILL JUST BARELY FELT STIMULATION AT/AROUND 9.5 VOLTS ON THE RIGHT SIDE. A DIFFERENT TRIALING CABLE AND ENS WERE REPORTEDLY TRIED. THE PHYSICIAN REPORTEDLY TOOK THE LEAD OUT AND THERE WAS NO BLOOD VISUALIZED ON THE LEAD, AND IT WAS REPORTEDLY VERY CLEAN. IT WAS NOTED THE STYLET WAS FULLY REMOVED DURING IMPEDANCE TESTING. NO FLUID WAS USED FOR LOSS OF RESISTANCE TECHNIQUE, JUST AIR. ADDITIONAL INFORMATION RECEIVED REPORTED AT THE TIME OF THE TRIAL, INTRAOP TESTING WAS ATTEMPTED. IT WAS NOTED ONE LEAD BEING RETURNED WAS NORMAL, BUT THE SECOND LEAD¿S IMPEDANCE READING DID NOT RESOLVE FOR AN HOUR AND A HALF. IT WAS NOTED THERE WERE HIGH IMPEDANCES RANGING BETWEEN 7000-9000 OHMS. X-RAYS WERE TAKEN AND REPROGRAMMING WAS PERFORMED. IT WAS NOTED LEADS WERE EXPLANTED. IT WAS NOTED THE LEAD WAS REPOSITIONED 2 DAYS LATER. AS A RESULT OF THE HIGH IMPEDANCES, THE PATIENT DID NOT PERCEIVE STIMULATION ON THE RIGHT SIDE OF THE BODY. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES RETURNED TO NORMAL RANGE AFTER 1.5 HOURS AND THE PATIENT PROCEEDED WITH THE TRIAL. ADDITIONAL INFORMATION RECEIVED REPORTED AN X-RAYS WERE PERFORMED AND FOUND THE LEAD POSITION WAS NORMAL ANATOMICALLY FOR BOTH AP AND LATERAL. IT WAS REPORTED THAT A FEW DAYS LATER, THE PATIENT AND MANUFACTURER REPRESENTATIVE (REP) WERE ABLE TO ACHIEVE PARESTHESIA STATUS POST MOVEMENT OF THE LEAD. ALL CONTACTS REPORTED SHOWED HIGH IMPEDANCES. AFTER THE REVISION OF THE TRIAL LEAD PLACEMENT, THE PATIENT WENT ON TO RECEIVE A SUCCESSFUL TRIAL. TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328652 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