BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 25112431 · Received May 7, 2026

    Report

    Report Number
    3012520654-2026-00200
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 900303 (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 3288-ACQ NEEDLE 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 POST-OPERATIVELY A CARDIAC ABLATION PROCEDURE WITH THE AFFERA MAPPING SYSTEM, THE PATIENT HAD STABLE VITAL SIGNS BUT WAS UNABLE TO REGAIN CONSCIOUSNESS AND REMAINED INTUBATED WITH DELAYED EXTUBATION. THE ANESTHESIOLOGIST SUSPECTED AN ANESTHESIA-RELATED ISSUE AND THE PATIENT WAS EVALUATED FOR POSSIBLE STROKE WITH A COMPUTED TOMOGRAPHY SCAN, WHICH WAS NEGATIVE FOR STROKE. THE PATIENT WAS EXTUBATED SEVERAL HOURS LATER AND WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE DAY LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115722 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001

    Patients

    Seq Age Sex Outcome Treatment
    1