BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 21577644 · Received March 11, 2025

    Report

    Report Number
    3006630150-2025-01424
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN:M365SC2408560, MODEL:SC-2408-56, SERIAL:(B)(6), BATCH:7080172. PRODUCT FAMILY: CLIK X MRI ANCHOR, UPN:M365SC43190, MODEL:SC-4319, BATCH:34066630.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE SCS LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308977 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7080274 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention