BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2160835 · Received July 7, 2011

    Report

    Report Number
    3007566237-2011-05218
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SLAVIN KV. TECHNICAL ASPECTS OF PERIPHERAL NERVE STIMULATION: HARDWARE AND COMPLICATIONS. PROG NEUROL SURG. 2011;24:189-202. SUMMARY: THE AUTHORS REPORT ON PERIPHERAL NERVE STIMULATION COMPLICATIONS SEEN SINCE (B)(6) 2000. THEY REVIEWED 40 PTS WITH PNS IMPLANTS WHO WERE FOLLOWED FOR LONGER THAN 30 MONTHS. REPORTABLE EVENT: THE AUTHORS REPORT ONE DEVICE WAS REMOVED AT 25 MONTHS DUE TO LOSS OF EFFECTIVENESS. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-05208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK LEAD