BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4819593 · Received June 4, 2015

    Report

    Report Number
    3007566237-2015-01563
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    September 2, 2010
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3587A, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    COLOMBO, E.V., MANDELLI, C., MORTINI, P., MESSINA, G., DE MARCO, N., DONATI, R., IRACE, C., LANDI, A., LAVANO, A., MEARINI, M., PODETTA,S., SERVELLO, D., ZEKAJ, E., VALTULINA,C., DONES, I. EPIDURAL SPINAL CORD STIMULATION FOR NEUROPATHIC PAIN: A NEUROSURGICAL MULTICENTRIC ITALIAN DATA COLLECTION AND ANALYSIS. ACTA NEUROCHIRURGICA. 2015 FEB 3 2015. DOI: 10.1007/S00701-015-2352-5. SUMMARY: SPINAL CORD STIMULATION (SCS) IS A TECHNIQUE USED WORLDWIDE TO TREAT SEVERAL TYPES OF CHRONIC NEUROPATHIC PAIN REFRACTORY TO ANY CONSERVATIVE TREATMENT. THE AIM OF THIS DATA COLLECTION IS TO ENFORCE EVIDENCE OF SCS EFFECTIVENESS ON NEUROPATHIC CHRONIC PAIN REPORTED IN THE LITERATURE AND TO SPECULATE ON THE USEFULNESS OF THE TRIAL PERIOD IN DETERMINING THE LONG¿TERM EFFICACY. MOREOVER, THE VERY LOW PERCENTAGE OF UNDESIRED SIDE EFFECTS AND COMPLICATIONS REPORTED IN OUR CASE SERIES SUGGESTS THAT ALL IMPLANTS SHOULD BE PERFORMED BY SIMILARLY WELL-TRAINED AND EXPERIENCED PROFESSIONALS. A MULTICENTRIC DATA COLLECTION ON A COMMON DATABASE FROM 11 ITALIAN NEUROSURGICAL DEPARTMENTS STARTED 3 YEARS AGO. TWO DIFFERENT TYPES OF ELECTRODES (PADDLE OR PERCUTANEOUS LEADS) WERE USED. OF 122 PATIENTS, 73 % (N=89) WERE SUBMITTED TO A TRIAL PERIOD, WHILE THE REMAINING PATIENTS UNDERWENT THE IMMEDIATE PERMANENT IMPLANT (N=33). STATISTICAL COMPARISONS OF CONTINUOUS VARIABLES BETWEEN GROUPS WERE PERFORMED. MOST OF THE PATIENTS (80 %) HAD PREDOMINANT PAIN TO THEIR LOWER LIMBS, WHILE ONLY 17 % OF PATIENTS HAD PREVALENT AXIAL PAIN. SIGNIFICANT REDUCTION IN PAIN, AS MEASURED BY VARIATION IN VISUAL ANALOGUE SCALE (VAS) SCORE, WAS OBSERVED AT LEAST 1 YEAR AFTER IMPLANTATION IN 63.8% OF THE CASES, 59.5% OF PATIENTS WHO UNDERWENT A TEST TRIAL AND 71.4% OF PATIENTS WHO UNDERWENT PERMANENT IMPLANT AT ONCE. NO STATISTICAL DIFFERENCES WERE FOUND BETWEEN THE LOWER-LIMB PAIN GROUP AND THE AXIAL PAIN GROUP. REPORTED EVENTS: IT WAS REPORTED THE PATIENT EXPERIENCED A FRACTURE OF THE CONNECTING CABLE. THE PATIENT¿S LEAD WAS REPLACED DUE TO THE ¿BREAK/FRACTURE¿ OF THE LEAD. IT WAS ¿UNKNOWN¿ WHETHER THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS EVENT MAY HAVE BEEN ORIGINALLY REPORTED AS PART OF REGULATORY REPORT #3007566237-2015-00995. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC PATIENT INFORMATION FROM THE ARTICLE OR TO MATCH THIS EVENT WITH THE PREVIOUSLY REPORTED EVENTS. PLEASE SEE THIS REGULATORY REPORT FOR ALL FUTURE FOLLOW-UP REGARDING THIS SPECIFIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363198 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention