BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24797439 · Received April 7, 2026

    Report

    Report Number
    3006630150-2026-02112
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 17, 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
    GA, 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: 7081455 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 LEAD MIGRATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71660 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7081350 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention