BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3920167 · Received July 8, 2014

    Report

    Report Number
    3006630150-2014-01538
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: INFINION 1X16 PERC LEAD KIT-50 CM; MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM); MODEL #: SC-4316, LOT #: 16071238, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. 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 HAD DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS INCLUDED SWELLING AND PAIN AT THE IPG SITE. IT WAS BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED PERIPHERALLY INSERTED CENTRAL CATHETERS (PICC LINE) ANTIBIOTIC AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397945 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention