BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 25156456 · Received May 12, 2026

    Report

    Report Number
    3006630150-2026-03102
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 12, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1416. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 226698. MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 16 IPG KIT. UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7093730. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7097051. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT THE REPLACEMENT OF THE SCS SYSTEM. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO STIMULATION ISSUES, WHILE THE LEADS WERE REPLACED DUE TO MIGRATION AND STIMULATION ISSUES. THE DEVICES WERE DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38012 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7098910 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1