BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4201335 · Received October 27, 2014

    Report

    Report Number
    3006630150-2014-02489
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-50, SERIAL: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM; MODEL: SC-8216-70, SERIAL: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM; MODEL: SC-4316, LOT: 16647622, 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 DEVELOPED INFECTION AT THE IPG SITE. THE SYMPTOMS INCLUDE SWELLING, REDNESS, DRAINAGE AND WARMTH AROUND THE IPG SITE. IT WAS BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED AND NOT DEVICE RELATED. ANTIBIOTICS WAS PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684502 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention