BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1153069 · Received September 8, 2008

    Report

    Report Number
    2029203-2008-00571
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P0300017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL # SC-2208-70, ST LINEAR LEAD, 70CM. MODEL # SC-2208-70, ST LINEAR LEAD, 70 CM. THE EXPLANTED MATERIALS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A PATIENT'S SYSTEM WAS EXPLANTED DUE TO FLUID BUILD-UP AROUND THE IPG SITE. THE PHYSICIAN BELIEVES THE BUILD UP WAS NOT DUE TO THE DEVICE, BUT BELIEVES IT WAS CAUSED BY THE PATIENT'S BODY REJECTING THE SYSTEM. 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