BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURHYTHM ZA410 (AF)

    MDR report key: 22894396 · Received August 26, 2025

    Report

    Report Number
    2182208-2025-04249
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 22, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MXD
    PMA / PMN Number
    K210484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE PRODUCT AND CLINICAL DATA WERE RECEIVED FOR EVALUATION. AFTER A THOROUGH AND METICULOUS REVIEW OF THE TWO EPISODES FROM THE PATIENT, OUR LICENSED ANNOTATIONS SPECIALISTS HAVE CONCLUDED THAT ALL EPISODES WERE CORRECTLY LABELED AND IDENTIFIED AS FALSE AF AND PROPERLY WITHHELD BY THE ARTIFICIAL INTELLIGENCE (AI) ALGORITHM FROM REMOTE MONITORING NETWORK. DURING EVALUATION USING THE VISUALIZATION PLATFORM, COULD SEE P WAVES AND ECTOPY (PREMATURE ATRIAL CONTRACTIONS (PAC) AND PREMATURE JUNCTIONAL COMPLEX (PJC)). THESE FINDINGS WERE CONFIRMED BY TWO MEMBERS OF THE ANNOTATION TEAM. THE MOST LIKELY CAUSE OF THE EVENT IS USER CONFUSION. THE INVESTIGATION DETERMINED THAT THE PRODUCT TESTED IN SPECIFICATION AND/OR PERFORMED AS INTENDED. NO DEVICE OR SERVICE HISTORY RECORD WAS PERFORMED BECAUSE THE WEBSITE IS NOT MANUFACTURED OR SERVICED. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID LNQ22. SERIAL# (B)(6). IMPLANTED: (B)(6) 2025. 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 THE EPISODES DETECTED BY THE IMPLANTABLE CARDIAC MONITOR (ICM) AS ATRIAL FIBRILLATION (AF) WERE ADJUDICATED AS FALSE AF BY THE ARTIFICIAL INTELLIGENCE (AI) ALGORITHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704809 ACCURHYTHM ZA410 (AF) RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION) MXD MEDTRONIC, INC. ZA410

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male "SEE H11....".