BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL TRIALING NEUROSTIMULATOR

    MDR report key: 2032525 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02259
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    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 THE PT WAS IMPLANTED WITH 2 LEADS FOR A TRIAL AROUND 9:00 AM. THE LEADS WERE INTRODUCED AT THE T1-T2 INNER SPACE AND ADVANCED TO THE C1 VERTEBRAL BODY. PARESTHESIA WAS OBTAINED IN BOTH ARMS FROM THE UPPER ARM TO THE FINGERS ON BOTH UPPER EXTREMITIES. THE PT WAS THEN TRANSFERRED TO THE RECOVERY ROOM. IN RECOVERY, THE PT WAS ABLE TO STAND, AMBULATE AND GET HIMSELF DRESSED. THE PT WAS DISCHARGED FROM THE RECOVERY ROOM LATER THE SAME MORNING. AFTER THE PT WAS DISCHARGED, AT 11:30 AM THE SAME DAY, THE PT WAS HAVING BACK PAIN. AN HOUR LATER, THE PT HAD NUMBNESS IN HIS BILATERAL LOWER EXTREMITIES. THE PT WAS ADVISED TO TURN THE STIMULATOR OFF TO SEE IF THIS RESOLVED THE NUMBNESS. THE NUMBNESS WAS STILL PRESENT WHEN THE STIMULATOR WAS OFF. THE PT WAS ADVISED TO GO TO THE HOSPITAL FOR A MEDICAL ASSESSMENT. THE PT WENT TO THE ER. AT THE ER, THE PT HAD MOTOR LOSS AT THE T4 LEVEL AND BELOW. THE LEADS WERE REMOVED, AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED NO EVIDENCE OF AN EPIDURAL HEMATOMA. AN MRI WAS THEN PERFORMED TO RULE OUT A SPINAL CORD ISCHEMIC EVENT. THE MRI SHOWED THE PT HAD AN EPIDURAL HEMATOMA. THE PT WAS DISCHARGED FROM THE HOSPITAL LATER THAT NIGHT AND ADMITTED TO A DIFFERENT FACILITY. THE PT UNDERWENT SURGERY TO EVACUATE THE EPIDURAL HEMATOMA. PER THE REPORTER, THE PT HAD BEEN EXTUBATED, AND SOME FUNCTION HAD RETURNED TO ONE LOWER EXTREMITY. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL TRIALING NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION 37022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other