BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA? MRI

    MDR report key: 21225661 · Received January 23, 2025

    Report

    Report Number
    3006630150-2025-00175
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 2, 2025
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL/BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H6. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6). BATCH: 7080698.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO LOSING STIMULATION ON PAIN AREAS, IT WAS ALSO CONFIRMED UNDER X-RAY LEAD MIGRATION. THE PATIENT IS DOING GREAT POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED PER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO LOSING STIMULATION ON PAIN AREAS, IT WAS ALSO CONFIRMED UNDER X-RAY LEAD MIGRATION. THE PATIENT IS DOING GREAT POST OPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS IT WAS RETAINED PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614553 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7077094 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1