BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1910362 · Received November 18, 2010

    Report

    Report Number
    3006630150-2010-02012
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO A NEUROLOGICAL DEFICIT IN THE PT'S RIGHT LEG. THE PT'S LEAD WAS HITTING A NERVE, WHICH SOON DEVELOPED INTO AN EPIDURAL HEMATOMA. THE PT'S SYMPTOMS WERE NUMBNESS AND LOSS OF FUNCTION IN HER RIGHT LEG. UPON EXPLANT, THE PT WAS ABLE TO REGAIN 50% MOBILITY HER LEG. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R SERIAL# (B)(4)| MODEL# SC-1110-02| IPG KIT (WITHOUT PULL-THROUGH TUNNELER),