BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE S DR MRI SURESCAN

    MDR report key: 9932476 · Received April 7, 2020

    Report

    Report Number
    3004209178-2020-06787
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    UDI-DI
    00643169634602
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3058 MGU IPG, IMPLANTED: (B)(6) 2019. 3889-28 MGU LEAD, IMPLANTED: (B)(6) 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY ARE HAVING TROUBLE CONNECTING THEIR HOME MONITOR TO THEIR IMPLANTABLE PULSE GENERATOR (IPG). 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
    396538 AZURE S DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W3DR01 00643169634602

    Patients

    Seq Age Sex Outcome Treatment
    1 5086MRI58 LEAD, 5086MRI52 LEAD