BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2760635 · Received September 26, 2012

    Report

    Report Number
    3007566237-2012-02318
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3874, SERIAL# UNKNOWN, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EPIDURAL HEMORRHAGE AFTER UNDERGOING A NEUROSTIMULATION TRIAL. THE TRIAL WENT WELL WITH NO PROBLEMS WITH PLACEMENT OR EXCESSIVE BLOOD. AFTER THE TRIAL THE PATIENT HAD PAIN WHEN SHE WENT TO THE BATHROOM. THE STIMULATOR WAS TURNED OFF AND DISCONNECTED. THE LEADS WERE EVENTUALLY PULLED; HOWEVER, THE PATIENT CONTINUED TO HAVE AN INCREASE OF PAIN. A MAGNETIC RESONANCE IMAGE WAS TAKEN, AND THE AN EPIDURAL HEMORRHAGE WAS FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN BUT WAS PRESUMED TO BE ASSOCIATED WITH THE LEADS. IT WAS NOTED THAT THE LEADS WERE INSERTED WITHOUT DIFFICULTY ON THE FIRST ATTEMPT BUT REQUIRED SIGNIFICANT PAIN RELIEF DURING THE PROCEDURE. APPROXIMATELY 2 HOURS AFTER PLACEMENT OF THE LEADS, THE PATIENT HAD SIGNIFICANT PAIN CHEST WALL PAIN (NON-CARDIAC PER EKG) WHICH DID NOT RESPOND TO IV MORPHINE. THE LEADS WERE THEN TAKEN OUT AND WITHIN 3 HOURS THE PATIENT HAD A DECOMPRESSIVE LAMINECTOMY PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R