BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1892649 · Received November 3, 2010

    Report

    Report Number
    3006630150-2010-01854
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT'S PRECISION SYSTEM WAS EXPLANTED. THE PT FELT THAT THE SYSTEM NO LONGER WORKED FOR HER. 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 CORPORATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MODEL #: SC-2218-50| SERIAL #: (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SERIAL #: (B)(4)