BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1150410 · Received September 5, 2008

    Report

    Report Number
    2029203-2008-00660
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG AND THE PADDLE LEAD WERE NOT AVAILABLE FOR THE EVALUATION AS THEY REMAIN IMPLANTED IN THE PATIENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING INTERMITTENT STIMULATION, DISCOMFORT IN LEGS AND WEIGHT LOSS. THE SURGEON DECIDED TO PERFORM POCKET REVISION. DURING POCKET REVISION IT WAS DETERMINED THAT THE PRECISION IMPLANT WAS FLIPPED IN THE POCKET. THE DOCTOR CORRECTED THE IPG ORIENTATION. THE DOCTOR ALSO OBSERVED BLOOD IN THE LEADS.

    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 37 YR Required Intervention ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| MODEL# SC-8120-70