BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1243697 · Received November 25, 2008

    Report

    Report Number
    2029203-2008-01023
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR EVALUATION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING A POCKET REVISION DUE TO THE IMPLANT MIGRATING, THE PHYSICIAN ELECTED TO EXPLANT THE PRECISION SYSTEM BECAUSE HE DID NOT WANT TO CHANCE ELECTROCAUTERY DAMAGE TO THE BATTERY. A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR WAS IMPLANTED.

    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 50 YR Required Intervention