BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 21837937 · Received April 15, 2025

    Report

    Report Number
    3004209178-2025-06428
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 15, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 2210 COMPETITOR LEAD, IMPLANT DATE (B)(6) 2010. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POTENTIAL ELECTROMAGNETIC INTERFERENCE OVERSENSING WAS NOTED ON STORED ELECTROGRAMS. THE IMPLANTABLE PULSE GENERATOR (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
    133948 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. W1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male 226T COMPETITOR LEAD.