BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2093960 · Received May 16, 2011

    Report

    Report Number
    3007566237-2011-03559
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    October 7, 2010
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION OF THE EPIDURAL SPACE AND ALSO HAD DETENTION TREMORS. PT SYMPTOMS INCLUDED FEVER (100.5 F), LETHARGY, LOW BACK PAIN, LEG WEAKNESS, AND DIFFICULTY VOIDING. THE SITE OF INFECTION WAS REPORTED AS THE LEAD/EXTENSION TRACT. THE PT WAS HOSPITALIZED AND AN MRI WITH CONTRAST WAS PERFORMED ON (B)(6) 2010. RESULTS SHOWED AND EPIDURAL LESION AT L1, L2, AND L3 CAUSING SPINAL CANAL STENOSIS (HEMATOMA VS ABSCESS). CULTURES TAKEN FROM THE EPIDURAL LUMBAR ABSCESS WERE (B)(6). A SURGICAL DECOMPRESSION LAMINECTOMY WAS PERFORMED ON (B)(6) 2010. THE PT WAS TREATED WITH VANCOMYCIN (1 GM INTRA-VENOUS FOR 6 WEEKS) AND FLAGYL. ADDITIONAL INFO WAS REQUESTED.

    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 NA Unknown Hospitalization| R EXPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNKNOWN.| IMPLANTED:| IMPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK. | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNK| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK