BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 24347972 · Received February 16, 2026

    Report

    Report Number
    3012520654-2026-00049
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 19, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    UDI-DI
    00763000871925
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E1, E2, E3. 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

    PRODUCT EVENT SUMMARY: THE PULSE FIELD GENERATOR WITH SERIAL NUMBER: (B)(6) WAS RETURNED AND ANALYZED. DURING EXTERNAL VISUAL INSPECTION, THE PFG WAS FOUND TO HAVE A DAMAGED ABLATION RETURN LINK CABLE CONNECTOR. THE PRODUCT ISSUE REPORTED, BROKEN CABLE CONNECTOR, IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; HOWEVER, THE RISK OF THE PATIENT BEING UNDER GENERAL ANESTHESIA WITHOUT FULL THERAPEUTIC EFFECT IS THE ADVERSE EVENT BEING REPORTED. THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGMENT OF THE PHYSICIAN. 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 PRIOR TO A CARDIAC ABLATION PROCEDURE, THE FRONT OF THE PULSE FIELD GENERATOR (PFG) WAS DAMAGED. THE ABLATION RETURN LINK CABLE WAS REPORTED TO BE "RIPPED" OUT OF THE FRONT OF THE SYSTEM. THE PROCEDURE WAS UNABLE TO START AND THE PATIENT WAS ALREADY UNDER GENERAL ANESTHESIA WHEN THE CASE WAS ABORTED. TECHNICAL SERVICES RECOMMENDED SERVICE FOR REPLACEMENT OF THE PFG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576017 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00008 00763000871925

    Patients

    Seq Age Sex Outcome Treatment
    1