BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19845732 · Received July 26, 2024

    Report

    Report Number
    3006630150-2024-04891
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    May 6, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    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: M365SC2408740 MODEL: SC-2408-74 SERIAL: (B)(6) BATCH: 7072962.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561841 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 7072952

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention