BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 12039140 · Received June 22, 2021

    Report

    Report Number
    3004209178-2021-09716
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634589
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3889-28 MGU LEAD, (B)(6) 2017; 3058 MGU IPG, IMPLANTED (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) IS NOT WORKING PROPERLY. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935093 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W1DR01 00643169634589

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR