BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1150395 · Received September 5, 2008

    Report

    Report Number
    2182207-2008-05499
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NERVE DAMAGE IN HIS RIGHT HEEL DURING A SPINAL CORD STIMULATION TRIAL LEAD IMPLANT. DURING IMPLANT OF THE TRIAL LEAD, THE PATIENT WAS SHOCKED AND HIS WHOLE BACK MOVED. THE PATIENT EXPERIENCED HIS WORSE PAIN WHEN HE GOT OUT OF BED AND BEGAN WALKING. THE HCP HAD REPROGRAMMED HIS DEVICE VARIOUS TIMES BUT WAS UNABLE TO COVER THE PAIN IN THE PATIENT'S HEEL. THE PATIENT WAS AT HOME AT THE TIME OF THE IMPLANT; HIS STATUS WAS REPORTED AS 'FAIR'. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION 37021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| LEAD MODEL LEAD LOT# UNK