BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 24541733 · Received March 8, 2026

    Report

    Report Number
    3006630150-2026-01360
    Event Type
    Injury
    Date Received
    March 8, 2026
    Date of Event
    November 18, 2024
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN FEW MONTHS PRIOR THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7117087. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 21349450. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 2000019543. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1160. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 330435. MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. UNIQUE IDENTIFIER (UDI): (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1416. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 212738. MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 16 IPG KIT. UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE WHEREIN ALL DEICE COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44913 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7116889 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention