BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1983948 · Received February 7, 2011

    Report

    Report Number
    3006630150-2011-00196
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT A PT WAS EXPERIENCING DULL, INTERMITTENT AND THROBBING PAIN IN THE RIGHT SIDE OF THE BODY DUE TO STIMULATION. THE PHYSICIAN PRESCRIBED PAIN MEDICATION. THE PHYSICIAN INDICATED THAT THE PAIN WAS CAUSED BY THE DEVICE AND THE MEDICATION WAS ADMINISTERED DUE TO THE PT'S STIMULATION DISCOMFORT.

    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 33 YR Required Intervention (B)(4)| (B)(4)| MODEL# SC-2218-50| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET