BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8952769 · Received August 30, 2019

    Report

    Report Number
    3006630150-2019-04699
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 11, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5153621, MODEL/CATALOG DESCRIPTION: LINEAR ST TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE TRIAL PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. SYMPTOM OF FEVER WAS NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENTS LEADS WERE REMOVED AND WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745546 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 5013891 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention