BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 7870233 · Received September 12, 2018

    Report

    Report Number
    3006630150-2018-60871
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    July 3, 2018
    Report Date
    September 12, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER : 5001373;; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD, 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICE(S) WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A LEAD REVISION PROCEDURE (MFR REPORT NO: 3006630150-2018-02167), THE PATIENT DEVELOPED AN INFECTION ON THE LEAD SITE AND WAS ADMITTED TO INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT ONE OF THE LEADS THAT WAS REVISED WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712518 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7001170 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention