BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1867717 · Received October 8, 2010

    Report

    Report Number
    3007566237-2010-07751
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    January 12, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - DIFFICULTY USING CHOPSTICKS - (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: WADA E, KAWAI H. LATE ONSET CERVICAL MYELOPATHY SECONDARY TO FIBROUS SCAR TISSUE FORMATION AROUND THE SPINAL CORD STIMULATION ELECTRODE. SPINAL CORD AUG 2010; 48(8):646-648. SUMMARY: THE OBJECTIVE OF THIS ARTICLE IS TO REPORT THE LATE ONSET OF CERVICAL MYELOPATHY SECONDARY TO FIBROUS SCAR TISSUE FORMATION AROUND AN EPIDURAL ELECTRODE IMPLANTED FOR SPINAL CORD STIMULATION (SCS) FOR A (B)(6) MAN WHO HAD AN ELECTRODE IMPLANTED FOR SCS 5 YEARS AGO ((B)(6)-2000). THE PT WAS REFERRED TO HE AUTHOR'S DEPARTMENT ON (B)(6)2005, COMPLAINING OF DIFFICULTY USING CHOPSTICKS AND WALKING. EVENT: NEUROLOGICAL EXAMINATION REVEALED SPASTIC QUADRIPARESIS WITH EXAGGERATED DEEP TENDON REFLEX IN THE PT'S LOWER EXTREMITIES. A COMPUTED TOMOGRAPHY SCAN WITH MYELOGRAPHY REVEALED SEVERE SPINAL CORD COMPRESSION AROUND THE EPIDURAL ELECTRODE. SURGICAL REMOVAL OF THE ELECTRODE ((B)(6)-2005) WAS NOT EFFECTIVE. REMOVAL OF FIBROUS SCAR TISSUE DURING A SECOND SURGERY SIGNIFICANTLY IMPROVED HIS NEUROLOGICAL SYMPTOMS AND DECOMPRESSED THE SPINAL CORD. HISTOLOGICAL EXAMINATION OF THE EPIDURAL MASS REVEALED FIBROUS SCAR TISSUE WITHOUT INFLAMMATORY CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED: