BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19509406 · Received June 11, 2024

    Report

    Report Number
    3006630150-2024-03753
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7073032/7074600.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT LEADS HAD MIGRATED AND WAS NOT ABLE TO COVER PATIENTS PAIN AREA. IT WAS NOTED ALSO THAT PATIENTS ANCHOR CAUSE DISCOMFORT. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807965 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 5075782 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention