BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15963232 · Received December 12, 2022

    Report

    Report Number
    3006630150-2022-06941
    Event Type
    Injury
    Date Received
    December 12, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 12, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AGO FROM THE DATE 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: 5132824.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WILL NOT BE RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407577 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5132823 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention