BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA? MRI

    MDR report key: 24017654 · Received January 9, 2026

    Report

    Report Number
    3006630150-2026-00207
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7090438. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK AFTER HER IMPLANT. THE PATIENT IS SCHEDULED TO RECEIVE A BLOOD PATCH FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81528 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7090363 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention