BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3182552 · Received June 21, 2013

    Report

    Report Number
    3006630150-2013-01296
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-4316, LOT #: 15932330, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE; MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). 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 MIDLINE INCISION SITE WHEREIN PUS AND OPENING AT THE SITE WAS NOTED. THE IPG POCKET SITE WAS RED AS WELL. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE AND WAS RESPONDING TO THE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283718 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention