BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 21810193 · Received April 9, 2025

    Report

    Report Number
    3006630150-2025-02292
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    February 1, 2025
    Report Date
    August 20, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7122081. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    THE RETURNED LEAD WITH MODEL OF SC-2218-50 AND A SERIAL OF (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. UNABLE TO CONFIRM THE AS REPORTED OBSERVATIONS WITH TESTING OF THE PRODUCT RETURN. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416322 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7121785 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention