BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1013814 · Received March 14, 2008

    Report

    Report Number
    2029203-2008-00116
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 13, 2008
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED PAIN IN THE RIGHT ARM, WHEN HE MOVES HIS HEAD. THE PHYSICIAN BELIEVES THIS MAY BE DUE TO LEAD MIGRATION AND HAS DECIDED TO EXPLANT THE MIGRATED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SC-2208-50