BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 21599921 · Received March 13, 2025

    Report

    Report Number
    3006630150-2025-01499
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    November 1, 2024
    Report Date
    March 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 232367. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(6), BATCH: 370147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION ISSUES. X-RAY AND REVEALED THAT ONE OF HIS TWO SPINAL CORD STIMULATION (SCS) LEADS HAS MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN BOTH LEADS, AND OLD IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482524 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 232616 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention