BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRECISION

    MDR report key: 1983873 · Received February 4, 2011

    Report

    Report Number
    3006630150-2011-00163
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S ENTIRE PRECISION SYSTEM WAS EXPLANTED. THE PT BELIEVED THAT WHEN THE DEVICE WAS TURNED ON, THE STIMULATION CAUSED HER PAIN. THE DEVICE WAS WORKING PROPERLY AND THE PT WAS DOING FINE AFTER THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SERIAL # - (B)(4)| LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012" STYLET| MODEL # - SC-2138-70, SERIAL # - (B)(4)