BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3933171 · Received July 14, 2014

    Report

    Report Number
    3006630150-2014-01601
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 22, 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

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #: 16533643 DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE MODEL #: SC-3400-30, SERIAL #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM), MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION:INFINION1X16 PERC LEAD KIT-50 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT PROCEDURE RELATED. THE PATIENT WAS INFECTED BY HER GRANDDAUGHTER, WHO HAD (B)(6). THE SYMPTOMS OF INFECTION WERE REDNESS, SWELLING, OOZING AND PAIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE RELATED. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE RELATED. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409673 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention