BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4241851 · Received November 10, 2014

    Report

    Report Number
    3006630150-2014-02592
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION1X16 PERC LEAD KIT-50CM; MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM). THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG POCKET SITE WAS INFECTED AND COULD NOT BE SALVAGED. THE SYMPTOMS INCLUDED SWELLING AND REDNESS AT THE IPG SITE AND BUMP AT THE LEAD SITE. ANTIBIOTICS WAS PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. IT WAS BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724092 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention