BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA? MRI

    MDR report key: 23478663 · Received November 5, 2025

    Report

    Report Number
    3006630150-2025-09983
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7085687, UDI: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7080630, UDI: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7080508, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT LEAD REPLACEMENT SURGERY DUE TO LEAD DISPLACEMENT, WHICH PREVENTED STIMULATION FROM REACHING THE TARGETED PAINFUL AREA. THIS ISSUE WAS CONFIRMED THROUGH MEDICAL IMAGING. THE PATIENTS POST-OPERATIVE CONDITION IS STABLE. THE EXPLANTED LEADS WILL NOT BE ANALYZED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692929 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-74 7079042 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention