BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1936031 · Received December 10, 2010

    Report

    Report Number
    3006630150-2010-02097
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT EXPERIENCED SEROMA AND SKIN EROSION AT THE IPG SITE. THE PT WAS EXPERIENCING PUS AND PURULENT DISCHARGE, AND THE IPG WAS VISIBLE THROUGH A SMALL HOLE IN THE SKIN. THE PHYSICIAN SUSPECTS INFECTION, ALTHOUGH THE PHYSICIAN DOES NOT BELIEVE THAT THE ISSUE WAS DEVICE OR PROCEDURE RELATED. THE PT UNDERWENT A PROCEDURE TO EXPLANT THE DEVICE. FOLLOWING THE EXPLANT PROCEDURE, THE PT WAS PRESCRIBED AUGMENTIN AND IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R MODEL #: SC-2158-70, (B)(4)| LINEAR LEAD, 70 CM WITH PRE-LOADED 0.014" STYLET