BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1971881 · Received January 19, 2011

    Report

    Report Number
    3006630150-2011-00082
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS PRESCRIBED LYRICA TO HELP HIM SLEEP AS HE FEELS RESIDUAL STIMULATION WHEN THE DEVICE IS TURNED OFF. THE MEDICATION WAS WORKING WELL AND THE PHYSICIAN IS TAKING NO FURTHER COURSE OF ACTION.

    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 Male Required Intervention 70 CM, MODEL # - SC-8120-70, SERIAL # - (B)(6)| ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| 70 CM, MODEL # - SC-8120-70, SERIAL # - (B)(4)| ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)