BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMED -ADVANCED NEUROMODULATION SYSTEMS, INC.-

    MDR report key: 451151 · Received March 26, 2003

    Report

    Report Number
    MW1027992
    Event Type
    Injury
    Date Received
    March 26, 2003
    Date of Event
    June 29, 1998
    Report Date
    March 26, 2003
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    1998 WAS THE DATE OF THE SPINAL STIMULATOR SURGERY WITH A PELVIC PAIN PT WHICH WAS AN ATTEMPTED LUMBAR AND SACRAL NERVE ROOT STIMULATOR IMPLANTATION, USING A NOVEL ANATOMICAL APPROACH AND NEURO STIMULATION TECHNIQUE IN THIS PELVIC PAIN PT, WITH A NEUROMED DUAL OCTRODE TRIAL SPINAL CORD STIMULATING CATHETER SYSTEM MANUFACTURED BY ADVANCED NEUROMODULATION SYSTEMS WITH THE SOFTWARE PACKAGE PAIN DOC. LEAD 1 MODEL 2198 KIT BI, N7354 X03. LEAD 2 MODEL NO 2198 LOT NO N7354 X03. A DURAL TEAR AND/OR PUNCTURE OCCURRED WITH SINAL FLUID LEAKAGE, A SPINAL HEADACHE, PHOTOPHOBIA AND VOMITING COMING OUT OF SURGERY. A BLOOD PATCH WAS PERFORMED. THE STIMULATION DEVICE WITH LEADS WAS NOT REMOVED POST SURGICALY UNTIL APPROXIMATELY 10 DAYS AFTER. WITH STIMULATION, THE PAIN GOT WORSE IN THE LEGS AND BUTTOCKS AREA. THE PT SUBSEQUENTLY DEVELOPED ARACHNOIDITIS, A CONDITION THAT HAS NO CURE AND HAS BEEN KNOWN TO GO TO PARALYSIS. ARACHNOIDITIS IS ALSO KNOWN TO SHORTEN THE LIFESPAN OF THE ARACHNOIDITIS SUFFERER BY APPROXIMATELY 12 YEARS. THE ARACHNOIDITIS WAS DIAGNOSED BY THE DEPT OF NEUROLOGY. IT INCLUDES CLUMPING OF THE NERVE ROOTS OF THE CAUDA EQUINA AT THE L2 AND 3 LEVELS. IT ALSO INCLUDES NERVE ROOTS WITHIN THE THECAL SAC APPEARING TO BE SOMEWHAT ADHESED WITH LESS SEPARATION THAN IS TYPICALLY IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMED -ADVANCED NEUROMODULATION SYSTEMS, INC.- NEUROMED DUAL OCTRODE TRIAL SPINAL CORD STIMULATING CATHETER GZB ADVANCED NEUROMODULATION SYSTEMS, INC. * *
    2 NEUROMED -ADVANCED NEUROMODULATION SYSTEMS, INC.- LEADS GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 2198 N73

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| S SOFTWARE PACKAGE-PAINDOC