BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 24536987 · Received March 6, 2026

    Report

    Report Number
    3006630150-2026-01337
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    November 15, 2025
    Report Date
    May 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO AND A HALF WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1216, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 756125, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 16 IPG KIT, UNIQUE IDENTIFIER (UDI)#: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7081287, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). BLOCK D2B: LGW, QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO THE MIGRATION AND IMPEDANCE OF THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A SCS REVISION PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491171 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7081105 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention