BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 23191969 · Received October 1, 2025

    Report

    Report Number
    3006630150-2025-08189
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 24, 2025
    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 D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6). BATCH: 7083729 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION STATED THAT THE PATIENT IS DOING OKAY WITH PROGRAMS. NOTHING WILL BE RETURNED. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795541 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7083670 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention