BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURE XT DR MRI SURESCAN

    MDR report key: 19511413 · Received June 11, 2024

    Report

    Report Number
    2182208-2024-02414
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    January 1, 2023
    Report Date
    June 11, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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: AN AUTOMATIC PACEMAKER ALGORITHM CAUSING EXERTIONAL INTOLERANCE. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2023; 34:2376¿2381. DOI: 10.1111/JCE.16104 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 AN AUTOMATIC PACEMAKER ALGORITHM CAUSING EXERTIONAL INTOLERANCE. THE AUTHORS DESCRIBED A PATIENT WHO DEVELOPED WORSENING EXERTIONAL DYSPNEA APPROXIMATELY TWO YEARS POST IMPLANT OF THEIR IMPLANTABLE PULSE GENERATOR (IPG). THEY OBSERVED A SIGNIFICANT DROP IN THEIR HEART RATE DURING PEAK ACTIVITY THAT PERSISTED THROUGH THE FIFTH MINUTE OF RECOVERY, WHICH CORRESPONDED WITH THE SYMPTOMS. THIS RESULTED IN PACEMAKER PSEUDO WENCKEBACH. AS THEIR ATRIAL RATE INCREASED ABOVE 150 BEATS PER MINUTE, 2:1 BLOCK OCCURRED BECAUSE THIS EXCEEDED THE TARP. THIS, IN TURN, REDUCED THE VENTRICULAR RATE AND INCREASED THE MEDIAN RR INTERVAL, RESULTING IN POST VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) LENGTHENING AS DETERMINED BY THE AUTOMATIC PVARP ALGORITHM. THE PATIENT WAS BROUGHT BACK TO THE PACEMAKER CLINIC AND THE SAME PHENOMENON OF UPPER RATE BEHAVIOR AND PERSISTENT 2:1 BLOCK WAS REPRODUCED DURING EXERCISE WHICH CONFIRMED THE SUSPICION THAT THIS WAS RELATED TO THE AUTO PVARP ALGORITHM. THE PVARP WAS REPROGRAMMED AND THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859593 AZURE XT DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. W1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention UNKNOWN LEADS