BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1243698 · Received November 25, 2008

    Report

    Report Number
    2029203-2008-01062
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED OF THE PATIENT'S PRECISION SYSTEM WILL BE EXPLANTED, DUE TO SKIN EROSION AT THE IPG POCKET SITE. THE PATIENT IS A TEENAGER, AND THE PHYSICIAN FEELS THE POCKET EROSION IS DUE TO THE PATIENT'S BODY GROWING. THE PATIENT IS UNDERGOING ANOTHER TYPE OF PAIN MANAGEMENT AND 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LINEAR LEAD (PHASE IIIA)