BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24695843 · Received March 26, 2026

    Report

    Report Number
    3006630150-2026-01793
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: LGW - QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7082850, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO INADEQUATE STIMULATION. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402368 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7082857 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention