BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1230013 · Received November 12, 2008

    Report

    Report Number
    2029203-2008-00980
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 16, 2007
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG REMAINS IMPLANTED IN THE PATIENT, AND WILL NOT BE RETURNED FOR EVALUATION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT OF PATIENT DISCOMFORT AT THE POCKET SITE WAS RECEIVED. A POCKET REVISION WAS PERFORMED TO RELOCATE THE PATIENT'S IMPLANT SITE. PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention