BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1276873 · Received January 2, 2009

    Report

    Report Number
    2029203-2008-01212
    Event Type
    Injury
    Date Received
    January 2, 2009
    Date of Event
    December 5, 2008
    Report Date
    December 5, 2008
    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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT THAT A PATIENT HAD A SKIN REACTION WAS RECEIVED. THE PATIENT BELIEVES THAT THE REACTION MAY BE CAUSED BY THE IPG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention