BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 24421221 · Received February 23, 2026

    Report

    Report Number
    3012520654-2026-00059
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    January 26, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000998363
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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. . MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE, AN ERROR MESSAGE STATING "NO SOUND DURING ABLATION" WAS DISPLAYED WHEN ATTEMPTING TO DELIVER A PULSED FIELD (PF) LESION ON THE POSTERIOR WALL/FLOOR LINE AFTER COMPLETION OF THE PULMONARY VEIN ISOLATION (PVI). THE ERROR PREVENTED FURTHER ABLATION AND COULD NOT BE CLEARED. THE SYSTEM WAS RESTARTED, AND THE POWER ON TEST RESULT INDICATED "RFG (RADIOFREQUENCY GENERATOR) TESTS PASSED, PFG (PULSED FIELD GENERATOR) WAS POWERED OFF." UPON A SECOND RESTART, THE SAME ERROR REGARDING PFG POWERED OFF WAS OBSERVED. DUE TO TIME CONSTRAINTS, THE PHYSICIAN DECIDED NOT TO RESTART THE SYSTEM AGAIN, AND THE PROCEDURE WAS ABORTED. WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478212 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00008 00763000998363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other