BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3923577 · Received July 9, 2014

    Report

    Report Number
    3006630150-2014-01550
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-50 SERIAL #:(B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT ABLE TO MOVE HER LEGS AFTER THE IMPLANT PROCEDURE. AN EPIDURAL HEMATOMA WAS SUSPECTED BASED ON CT FINDINGS. THE PHYSICIAN BELIEVED THAT THE EVENT WAS PROCEDURE RELATED. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. MEDICATION INTERVENTION WAS PROVIDED. SPINAL DECOMPRESSION WAS PERFORMED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND HAD REGAINED SENSORY IN BOTH LEGS AND MOTOR SKILLS WERE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399754 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention