BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1130909 · Received August 21, 2008

    Report

    Report Number
    2029203-2008-00538
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8120-70. DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES). THE EXPLANTED DEVICE WILL NOT BE EVALUATED AS IT WAS DISCARDED BY MEDICAL FACILITY.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING INFECTION. THE DR EXPLANTED PT'S PRECISION SYS AND PT WAS TREATED WITH IV ANTIBIOTICS. THE PT'S INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention