BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1800877 · Received August 10, 2010

    Report

    Report Number
    3006630150-2010-01382
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 10, 2010
    Report Date
    July 21, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TWO WEEKS FOLLOWING THE IMPLANT OF THE IPG, THE PATIENT WAS EXPERIENCING A DISCHARGE AT THE INCISION SITE. THE IPG WAS REPOSITIONED IN (B)(6) 2010. THE PATIENT IS STILL EXPERIENCING A DISCHARGE. THE NEXT COURSE OF ACTION HAS NOT BEEN DETERMINED AT THIS TIME.

    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 Required Intervention