BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3132829 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01094
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50E, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD AND SPLITTER 2X8 KITS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVED THAT PATIENT'S HEMATOMA WAS PROCEDURE RELATED. SC-2316-50E SN: (B)(4). THE COMPLAINT OF BLOOD/BODILY FLUID BEING VISIBLE IN THE LEAD MULTI LUMEN TUBING WAS CONFIRMED. THERE ARE NO PUNCTURES OR HOLES IN THE OUTER TUBING. THE FLUID LIKELY ENTERED THROUGH THE STYLET CHANNEL DURING THE PROCEDURE. THE DHR FOR THIS DEVICE WAS REVIEWED AND INDICATED THE DEVICE PASSED A FINAL QUALITY INSPECTION THAT WOULD HAVE CAUGHT THIS SORT OF DEFECT. SC-2316-50E SN: (B)(4), DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL EXAM. DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THE PHYSICIAN NOTICED BLOOD INSIDE THE EXPLANTED LEADS. MRI WAS TAKEN AND REVEALED PATIENT HAD AN EPIDURAL HEMATOMA. THE PATIENT MANIFESTED LEFT LEG SPASM, SEVERE MUSCLE SPASM AND WEAKNESS IN THE WHOLE UPPER BACK. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND WAS TREATED WITH MEDICATION. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD PULL, THE PHYSICIAN NOTICED BLOOD INSIDE THE EXPLANTED LEADS. MRI WAS TAKEN AND REVEALED PATIENT HAD AN EPIDURAL HEMATOMA. THE PATIENT MANIFESTED LEFT LEG SPASM, SEVERE MUSCLE SPASM AND WEAKNESS IN THE WHOLE UPPER BACK. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND WAS TREATED WITH MEDICATION. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233968 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R