BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1241177 · Received November 20, 2008

    Report

    Report Number
    2029203-2008-00937
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS REC'D STATING THE PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO SKIN EROSION AT THE POCKET SITE. A NEW PRECISION SYSTEM WAS IMPLANTED. THE PHYSICIAN STATES THAT PT CURRENTLY HAS HEALTH ISSUES CAUSING THE POCKET TO ERODE. PT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| MODEL# - SC-8120-50