BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24622268 · Received March 17, 2026

    Report

    Report Number
    3006630150-2026-01576
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    November 2, 2025
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER A WEEK AGO FROM DATE MANUFACTURER WAS MADE AWARE. D2B: PRO CODE: QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER:SC-2352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER:7081881, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM, UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER:SC-1416, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER:228511, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 16 IPG KIT, UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER:SC-4318, BATCH/LOT NUMBER:34205188, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES FOLLOWING A FALL AND MIGRATED ALL THE WAY DOWN TO THE BATTERY AS CONFIRMED VIA X-RAY. THE PATIENT ALSO NOTED SHIFT IN COVERAGE. THE PATIENT UNDERWENT SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29200 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7081904 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention