BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 22015781 · Received May 13, 2025

    Report

    Report Number
    3006630150-2025-03325
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    January 3, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7040959, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCE INTERMITTENT STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCE INTERMITTENT STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230245 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 368849 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention