BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 23977290 · Received January 6, 2026

    Report

    Report Number
    3006630150-2026-00116
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7111194. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES POST PERMANENT IMPLANT PROCEDURE. TRIED DRY/WET WIPE BUT DID NOT RESOLVE THE ISSUE. DOCTOR CHOSE TO NOT REPLACE LEAD DUE TO ALREADY LONG PROCEDURE TIME AND CLOSED UP WITH ONE REMAINING IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39988 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7110819 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other