BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 14050834 · Received April 8, 2022

    Report

    Report Number
    3008973940-2022-01492
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 8, 2022
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    UDI-DI
    00763000316846
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: EVPROPLUS-34US VALVE, IMPLANTED ON (B)(6) 2022. M IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING APPROXIMATELY ONE DAY POST IMPLANT. THE RA LEAD REMAINS IN USE. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING AT A RATE LOWER THAN THE PROGRAMMED LOWER RATE. 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
    1283508 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS W1DR01 00763000316846

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male 5076-45 LEAD 383069 LEAD