BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-6

    MDR report key: 25262927 · Received May 22, 2026

    Report

    Report Number
    3006630150-2026-02970
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    January 7, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL APPLICABLE PRODUCT CODE FIELD D2B: QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6 UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7082579. UDI# (B)(4). BRAND NAME: LINEAR 3-6 UPN: M365SC2366500 MODEL: SC-2366-50 SERIAL: (B)(6). BATCH: 7080539 UDI# (B)(4). BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7078709. UDI# (B)(4). BRAND NAME: WAVEWRITER ALPHA 32 IPG UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 765467. UDI# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED MIGRATION ON ALL THE SPINAL CORD STIMULATION (SCS) LEADS. IMAGING WAS TAKEN TO CONFIRM LEAD MIGRATION. THE PATIENT OPTED TO HAVE ALL FOUR LEADS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXPLANTED. THE PATIENT ALSO EXPERIENCED STIMULATION ISSUES FOR THREE MONTHS DUE TO THE LEAD MIGRATION. THE PATIENT HAD SYMPTOMS OF PAIN AND DISCOMFORT AT THE LEFT SIDE OF THE THORACIC RIB CAGE. IT WAS NOTED THAT THE PATIENT'S PAIN WAS PRE-EXISTING AND IT WAS MODERATE IN SEVERITY. HOWEVER, THE PATIENT'S DISCOMFORT WAS CONSTANT. ALL EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551262 LINEAR? 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7082013 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1