BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2656876 · Received July 16, 2012

    Report

    Report Number
    3007566237-2012-01656
    Event Type
    Injury
    Date Received
    July 16, 2012
    Date of Event
    January 5, 2012
    Report Date
    June 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: SARUBBO, S., LATINI, F., TUGNOLI, V., QUATRALE, R., GRANIERI, E., CAVALLO, M. A. SPINAL ANESTHESIA AND MINIMAL INVASIVE LAMINOTOMY FOR PADDLE ELECTRODE PLACEMENT IN SPINAL CORD STIMULATION: TECHNICAL REPORT AND CLINICAL RESULTS AT LONG-TERM FOLLOWUP. THE SCIENTIFIC WORLD JOURNAL; 2012: VOLUME: 2012, ARTICLE ID: 201053. SUMMARY: WE ARRANGED A MINI-INVASIVE SURGICAL APPROACH FOR IMPLANTATION OF PADDLE ELECTRODES FOR SCS UNDER SPINAL ANESTHESIA OBTAINING THE BEST PADDLE ELECTRODE PLACEMENT AND MINIMIZING PATIENTS' DISCOMFORT. WE DESCRIBE OUR TECHNIQUE SUPPORTED BY NEUROPHYSIOLOGICAL INTRAOPERATIVE MONITORING AND CLINICAL RESULTS. SIXTEEN PATIENTS, AFFECTED BY NEUROPATHIC PAIN UNDERWENT THE IMPLANTATION OF PADDLE ELECTRODES FOR SPINAL CORD STIMULATION IN LATERAL DECUBITUS UNDER SPINAL ANESTHESIA. THE PADDLE WAS INTRODUCED AFTER FLAVECTOMY AND EACH PATIENT CONFIRMED THE CORRECT DISTRIBUTION OF PARESTHESIAS INDUCED BY INTRAOPERATIVE TEST STIMULATION. VAS AND PATIENTS' SATISFACTION RATE WERE RECORDED DURING THE FOLLOW-UP AND COMPARED TO PREOPERATIVE VALUES. NO PATIENTS REPORTED DISCOMFORT DURING THE PROCEDURE. IN ALL CASES, PARESTHESIAS COVERAGE OF THE TOTAL PAINFUL REGION WAS ACHIEVED, ALLOWING THE BEST FINAL ELECTRODE POSITIONING. AT THE LAST FOLLOW-UP (MEAN 36.7 MONTHS), 87.5% OF THE IMPLANTED PATIENTS HAD A GOOD RATE OF SATISFACTION WITH A MEAN VAS SCORE IMPROVEMENT OF 70.5%. SPINAL CORD STIMULATION UNDER SPINAL ANESTHESIA ALLOWS AN OPTIMAL POSITIONING OF THE PADDLE ELECTRODES WITHOUT ANY DISCOMFORT FOR PATIENTS OR NEUROSURGEONS. THE BEST INTRAOPERATIVE POSITIONING ALLOWS A BETTER POSTOPERATIVE CONTROL OF PAIN, AVOIDING THE RISK OF BLIND PLACEMENTS OF THE PADDLE OR FURTHER SURGERY FOR THEIR REPLACEMENT. REPORTED EVENT: PATIENT 7, A (B)(6) FEMALE, DEVELOPED A SEVERE RIGHT LEG PARESIS CAUSED BY AN EPIDURAL HEMATOMA THAT REQUIRED EMERGENCY INTERVENTION. AFTER HEMATOMA EVACUATION, THE PATIENT RECOVERED FROM ALL SYMPTOMS AND THE PADDLE ELECTRODE WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention