BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18442236 · Received January 4, 2024

    Report

    Report Number
    3006630150-2023-08357
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    July 22, 2022
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL:(B)(6), BATCH: 7100831. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320, MODEL: M365SC12320, SERIAL: (B)(6), BATCH: 528109.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING. IT WAS NOTED THAT THE LEADS MIGRATED AND HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559910 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7100822 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention