BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 13023917 · Received December 17, 2021

    Report

    Report Number
    3008973940-2021-04696
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 17, 2021
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    UDI-DI
    00763000316846
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT"ALL OF THE SUDDEN MY PACEMAKER STARTED PACING ME AT 130-135 BPM" AND ARE CONCERNED THEIR IMPLANTABLE PULSE GENERATOR (IPG) ISN'T WORKING PROPERLY. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929530 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS W1DR01 00763000316846

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male 507658 LEAD, 507652 LEAD