BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1821481 · Received August 25, 2010

    Report

    Report Number
    3006630150-2010-01422
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT HAD AN INFECTION AT THE LEAD INCISION SITE. THE INCISION WAS OPEN, AND THE PT WAS EXPERIENCING DRAINING AND REDNESS. THE IPG SITE WAS RED AND POSSIBLY INFECTED, BUT THIS WAS NOT CONFIRMED. THE PT WAS TREATED WITH IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R ST LINEAR LEAD, 50 CM W/ PRE-LOADED 0.014" STYLET| MODEL # SC-2218-50| SERIAL # (B)(4)| MODEL # SC-1110-02| IPG KIT WITHOUT PULL-THROUGH TUNNELER| SERIAL # (B)(4)