BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1241181 · Received November 20, 2008

    Report

    Report Number
    2029203-2008-00945
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    August 25, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT OF THE PT'S PRECISION SYSTEM THAT WAS EXPLANTED DUE TO DISCOMFORT AT THE POCKET SITE WAS REC'D. THE PT DECLINED TO HAVE THE IPG MOVED TO A MORE COMFORTABLE LOCATION AND ELECTED TO BE 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 70 YR Required Intervention LINEAR LEAD (PHASE IIIA)