BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 21865908 · Received April 18, 2025

    Report

    Report Number
    3006630150-2025-02595
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    July 22, 2024
    Report Date
    May 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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)(6), BATCH: 7111953, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO HAVING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO HAVING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764623 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7111951 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention