BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2160845 · Received July 7, 2011

    Report

    Report Number
    3007566237-2011-05210
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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, INTENTIONS 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 REVISION DUE TO LEAD EROSION 4 WEEKS AFTER IMPLANTATION. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-05208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK