BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 25256212 · Received May 22, 2026

    Report

    Report Number
    2182208-2026-29591
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    December 3, 2024
    Report Date
    May 22, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: TANDEM APPROACH FOR TRANSVENOUS LEAD EXTRACTION: EFFICACY, SAFETY, AND OPERATIONAL LEARNING CURVE. JOURNAL OF CA RDIOVASCULAR ELECTROPHYSIOLOGY. 2026. 37:282¿295. DOI: 10.1111/JCE.70207. 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

    LITERATURE WAS REVIEWED REGARDING A TANDEM APPROACH FOR TRANSVENOUS LEAD EXTRACTION. THE AUTHORS DESCRIBED A PATIENT WHO UNDERWENT DEVICE AND LEAD EXTRACTION DUE TO DEVICE-RELATED ENDOCARDITIS WITH TRICUSPID VALVE VEGETATION AND SEPSIS. THE PATIENT DIED THE FOLLOWING DAY AFTER THE EXTRACTION PROCEDURE DUE TO MIXED SHOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68160 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. W2DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown Death 5076 LEAD