BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1230256 · Received November 13, 2008

    Report

    Report Number
    2029203-2008-00889
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 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 Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVAL, AS THEY ARE IN THE POSSESSION OF THE PATIENT'S ATTORNEY.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT A PT'S SYSTEM WAS EXPLANTED, DUE TO SKIN EROSION AND INFECTION. THE PT HAS BEEN PRESCRIBED ANTIBIOTICS.

    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 MODEL # SC-3138-35| ARTISAN 2X8 PADDLE LEAD| LEAD EXTENSION