BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1864468 · Received October 6, 2010

    Report

    Report Number
    3007566237-2010-07635
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SMITH CC, LIN JL, SHOKAT M, DOSANJH SS, CASTHELY D. A REPORT OF PARAPARESIS FOLLOWING SPINAL CORD STIMULATOR TRIAL, IMPLANTATION AND REVISION. PAIN PHYSICIAN. JUL 2010;13(4):357-363. SUMMARY: THE INCIDENCE OF SPINAL CORD INJURY AFTER (B)(4) TRIAL, IMPLANTATION AND REVISION IS UNK. FOUR PTS ARE PRESENTED WHO WERE ADMITTED TO AN ACUTE SPINAL CORD REHABILITATION HOSPITAL OVER A 4-MONTH PERIOD. ALL 4 PTS PRESENTED WITH PARAPARESIS AFTER SPINAL CORD STIMULATOR TRIAL OR IMPLANTATION. EVENT: THE PT UNDERWENT IMPLANTATION OF A SPINAL CORD STIMULATOR WITH BIPOLAR LEADS; THIS IMPROVED LOWER EXTREMITY SYMPTOMS BUT DID NOT AFFECT LOWER BACK PAIN. LATER, THE PT HAD A REVISION WITH PLACEMENT OF TRIPOLAR PADDLE LEADS AND T8-T9 LAMINECTOMY TO IMPROVE PT'S BACK PAIN. FOLLOWING THIS REVISION, THERE WAS LOWER EXTREMITY WEAKNESS (GREATER ON RIGHT); IT WAS DIFFICULT TO URINATE WITH A LOSS OF SENSATION AROUND THE LOWER ABDOMEN. ON POST-OPERATIVE DAY #1, NEUROSTIMULATOR AND LEADS WERE REMOVED. PT WENT HOME ON POST-OP DAY #2. PT RETURNED TO THE EMERGENCY DEPARTMENT 3 HOURS LATER COMPLAINING OF ONGOING SENSORY CHANGES, INABILITY TO VOID, AND INABILITY TO AMBULATE SECONDARY TO RIGHT LEG WEAKNESS. AN MRI ON POST-OP DAY #3 SHOWED NO EVIDENCE OF CORD COMPRESSION OR EPIDURAL HEMATOMA. MRI WAS REPEATED ON POST-OP DAY #5 AND DID SHOW SLIGHT SIGNAL ENHANCEMENT AT THE T8/T9 LEVEL. THE PT PARTICIPATED IN COMPREHENSIVE INTERDISCIPLINARY REHABILITATION. THE PT EXPERIENCED FULL RETURN OF MOTOR STRENGTH IN THE LEFT LEG, BUT ONLY PARTIAL RETURN ON THE RIGHT. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED.

    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 59 YR Required Intervention| S EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| IMPLANTED: