BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1243703 · Received November 25, 2008

    Report

    Report Number
    2029203-2008-00984
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 3, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A PT HAD A POCKET REVISION DUE TO DISCOMFORT WITH THE POCKET PLACEMENT. DURING THE REVISION, THE IPG WAS EXPLANTED DUE TO POSSIBLE INFECTION. A NEW IPG WAS IMPLANTED IN A MORE COMFORTABLE POSITION. THE 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 69 YR Required Intervention