BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4183325 · Received October 18, 2014

    Report

    Report Number
    3006630150-2014-02354
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50E, SERIAL/LOT #: (B)(4), DESCRIPTION: TRIAL LINEAR ST LEAD, 50CM. 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 AN INFECTION DURING THE TRIAL PERIOD. THE TRIAL PATIENT HAD AN EPIDURAL ABSCESS, FEVER AND BACK PAIN. THE PATIENT WENT TO THE HOSPITAL AND THE LEADS WERE PULLED. A LOT OF PUS CAME OUT. INTRAVENOUS ANTIBIOTICS WERE PRESCRIBED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED AND NOT DEVICE RELATED. THE PATIENT WAS RELEASED FROM THE HOSPITAL BUT HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663747 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R