BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15076732 · Received July 21, 2022

    Report

    Report Number
    3006630150-2022-03595
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    May 27, 2022
    Report Date
    January 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 7081703.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCKS B5, D6B AND H6 (IMPACT CODES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING OPTIMAL PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT AN LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RELEASED PER FACILITY PROTOCOL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING OPTIMAL PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE LEADS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719438 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7081565 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention