BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000971 · Received February 18, 2011

    Report

    Report Number
    3006630150-2011-00223
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT'S STIMULATION CAUSED THE WHEELCHAIR BOUND PT TO STRAIGHTEN OUT HER KNEE. THE PT WENT TO THE ER AND WAS INFORMED SHE HAD STRAINED A LIGAMENT. SHE WAS INSTRUCTED TO ELEVATE HER LEG AND ICE HER KNEE, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PT MET WITHOUT AN ORTHOPEDIC SURGEON WHO DETERMINED THAT THE PT'S FEMUR BONE WAS BROKEN. THE PT'S PHYSICIAN CONFIRMED THE BROKEN BONE WAS DEVICE RELATED. THE PT'S LEG WAS PLACED IN A SPLINT. THE PT WAS REPROGRAMMED WITH LOWER SETTINGS BY THE BSN SALES REP AND IS RECEIVING ADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention MODEL # SC-8216-70, SERIAL # (B)(4)| ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM