BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 7932409 · Received October 3, 2018

    Report

    Report Number
    3006630150-2018-61184
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 3, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER:SC-2208-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER:181455. MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 50CM. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE 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 PATIENTS LEADS WERE HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773043 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-50 181603

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention