BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 2210279 · Received August 9, 2011

    Report

    Report Number
    3007566237-2011-06160
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A TRIAL, THE PT EXPERIENCED WEAKNESS IN HER LOWER EXTREMITIES. AN MRI REVEALED AN EPIDURAL HEMATOMA. THE PT WAS BROUGHT BACK INTO THE OPERATING ROOM FOR SURGERY. THE HCP REPORTED THE PT CONDITION AS MUCH IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD: MODEL 3778, LOT# V646834038| EXPLANTED: