BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1192104 · Received October 7, 2008

    Report

    Report Number
    2029203-2008-00721
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 COMPLAINT WAS REC'D THAT A PT WAS EXPERIENCING DISCOMFORT. THE PHYSICIAN DETERMINED THE PT HAD AN INFECTION. THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED. THE INFECTION WAS DETERMINED TO BE MRSA AND THE PT WAS ADMINISTERED ANTIBIOTICS. THE PT IS REPORTEDLY DOING WELL.

    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 ST LENEAR LEAD| ST LINEAR LEAD