BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 22159868 · Received June 6, 2025

    Report

    Report Number
    3006630150-2025-04014
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    February 14, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN H6. B3: ESTIMATED BASED ON GFE RESPONSE FROM SALES REPRESENTATIVE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7081744, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE DUE TO LEADS MIGRATION, AS A CONSEQUENCE, THE PATIENT WAS NO LONGER RECEIVING PAIN RELIEF. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WERE RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE DUE TO LEADS MIGRATION, AS A CONSEQUENCE, THE PATIENT WAS NO LONGER RECEIVING PAIN RELIEF. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WERE RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478912 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7081598 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention