BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1230264 · Received November 13, 2008

    Report

    Report Number
    2029203-2008-00896
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 15, 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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D OF A PT HAVING SWELLING FROM HIS FEET TO HIS KNEES ALONG WITH LOSS OF BALANCE AND WEAKNESS. THE PT WAS INSTRUCTED TO TURN OFF THE STIMULATION BY HIS PHYSICIAN, AND THE SWELLING SUBSIDED. IT HAS BEEN RECOMMENDED THAT THE PT HAS THE SYSTEM EXPLANTED.

    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 Required Intervention ST LINEAR LEAD