BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA? MRI

    MDR report key: 21459869 · Received February 25, 2025

    Report

    Report Number
    3006630150-2025-01010
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: 19971121, UDI: (B)(4).

    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: 19971121.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEAD DUE TO FRACTURE. LEAD FRACTURE WAS NOT CONFIRMED THROUGH IMAGING. IT WAS ALSO NOTED THAT THE LEAD HAD MIGRATED AS CONFIRMED VIA FLUOROSCOPY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED AND WILL NOT BE RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEAD DUE TO FRACTURE. LEAD FRACTURE WAS NOT CONFIRMED THROUGH IMAGING. IT WAS ALSO NOTED THAT THE LEAD HAD MIGRATED AS CONFIRMED VIA FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417478 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 19971121

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female