BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANS

    MDR report key: 2147417 · Received June 27, 2011

    Report

    Report Number
    MW5021169
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANS - REP TERRI GUCHES
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL LOWER EXTREMITY PARALYSIS FOLLOWING PLACEMENT OF SPINAL CORD STIMULATOR (ALSO HAD EPIDURAL HEMATOMA). IN RECOVERY HAD NORMAL NEUROLOGIC FUNCTION AND SEVERAL HRS LATER WHILE PREPARING FOR DISCHARGE HAD BACK PAIN, REQUESTED MORPHINE, ROLLED TO SIDE - SHORTLY AFTER THAT BEGAN TO NOTICE WORSENING NUMBNESS FOLLOWED BY MOTOR WEAKNESS. TAKEN EMERGENTLY BACK TO OPERATING ROOM WHERE SMALL HEMATOMA SUBFASCIALLY AT THORACIC REGION WAS FOUND. NO EVIDENCE THAT THE SPINAL CORD STIMULATOR OR ANCHORS HAD SHIFTED. NO EVIDENCE OF DIRECT SPINAL CORD TRAUMA. HEMATOMA DID NOT APPEAR TO BE UNDER SIGNIFICANT PRESSURE - WAS ASPIRATED. PROBING AREA OF STIMULATOR REVEALED SOME SPONGY PARTIALLY MATURE HEMATOMA. A REVISION LAMINECTOMY WAS PERFORMED. STIMULATOR WAS REMOVED. ADMITTED TO HOSPITAL FOR OBSERVATION. THIRTY MINUTES POSTOP, PT APPEARED TO BE NEUROLOGICALLY NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS LEAD PENTA SPINAL CORD STIMULATOR LGW ANS - REP TERRI GUCHES MANF #3228 3339584

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization