BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1222034 · Received November 6, 2008

    Report

    Report Number
    2029203-2008-00993
    Event Type
    Injury
    Date Received
    November 6, 2008
    Report Date
    October 9, 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 EXPLANTED DEVICE WILL NOT BE EVALUATED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT OF THE PATIENT'S PRECISION SYSTEM EXPLANTED DUE TO INFECTION. THE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| MODEL # SC-8120-50