BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3911279 · Received July 2, 2014

    Report

    Report Number
    3006630150-2014-01511
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT BENT OVER AND HEARD SOMETHING POP. THE PATIENT HAD HEADACHE AND PAIN IN THE LOWER BACK AND WAS ADMITTED IN THE HOSPITAL. THE PHYSICIAN MONITORED THE PATIENT FOR COMPLICATIONS FOR OCCURRENCE OF SPINAL FLUID. THE PHYSICIAN BELIEVED THAT THE EVENT WAS PROCEDURE RELATED DURING THE INSERTION OF THE LEAD. THE PATIENT UNDERWENT A DRAINAGE PLUG AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385719 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R