BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 23832228 · Received December 17, 2025

    Report

    Report Number
    3012520654-2025-00233
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 18, 2025
    Report Date
    April 22, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQK
    UDI-DI
    00763000871925
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE AFR-00008 AFFERA¿ HEXAPULSE¿ PF GENERATOR (PFG) WITH SERIAL NUMBER (B)(6) WAS ANALYZED AND REPAIRED. DURING VISUAL INSPECTION, THE PFG WAS FOUND TO BE INTACT AND NO DAMAGE WAS PRESENT ON THE DEVICE. THE PFG WAS THEN FUNCTIONALLY TESTED WITH THE ASSOCIATED CATHETER INTERFACE UNIT (CIU). THE SYSTEM WAS BOOTED UP AND THE ERROR MESSAGE OF "FIRMWARE VERSION MISMATCH" WAS SEEN. THE TEST RADIOFREQUENCY GENERATOR (RFG) WAS REPLACED FOR ONE WITH A NEW FIRMWARE VERSION AND THIS ALLOWED THE SYSTEM TO BOOT UP NORMALLY WITH NO ISSUES. IN CONCLUSION, THE REPORTED ERROR MESSAGE WAS CONFIRMED DURING TESTING AND THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGEMENT 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID AFR-00003 ((B)(6)); PRODUCT TYPE: 2004-MAPPING HARDWARE; 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. 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 DURING A CARDIAC ABLATION PROCEDURE, A PULSE FIELD GENERATOR(PFG)/CATHETER INTERFACE UNIT (CIU) ERROR OCCURRED, AND A CIU FIRMWARE VERSION MISMATCH. THE COMMUNICATION CABLES WERE RECONNECTED WITHOUT RESOLVE. THE ELECTROGRAM SIGNALS DROPPED WHILE RESPIRATION CONTINUED. TO RESOLVE THE ISSUE, THE CASE WAS EXITED AND RE-ENTERED ALONG WITH REBOOTING AND RESULTED IN NOT BEING ABLE TO PACE. THE CATHETER TEMPERATURE SENSOR FAULT LED TO THE CATHETER BEING REPLACED TWO TIMES, WITH THE ERROR NOT CONSISTENTLY ASSOCIATED WITH ONE ELECTRODE. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT RECEIVED TREATMENT FOR PULMONARY VEIN ISOLATION (PVI) AND DID NOT GET PRE-EMPTIVE CAVOTRICUSPID ISTHMUS (CTI) ABLATION FOR TYPICAL FLUTTER. SERVICE RECOMMENDED REPLACEMENT OF THE PFG/CIU. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80413 AFFERA COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MEDTRONIC, INC. AFR-00008 00763000871925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11...