BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15420325 · Received September 14, 2022

    Report

    Report Number
    3006630150-2022-04743
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7103762.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LINEAR LEADS WERE NOT RETURNED AS THEY WERE NOT RELEASED FROM THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364948 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7103271 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention