BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 24420896 · Received February 23, 2026

    Report

    Report Number
    3012520654-2026-00060
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    PMA / PMN Number
    P240013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE FILES SHOWED THE FOLLOWING MESSAGES WERE RECEIVED. (B)(6) 2026 11:39:27 CIU WARNING MAGNETIC TRACKING INITIALIZING' (B)(6) 2026 11:39:36 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2026 11:45:02 CRITICAL NO POSTERIOR PATCH DETECTED' (B)(6) 2026 11:45:43 RFG INFORMATION SETTINGS SCREEN OPEN ON ABL REMOTE' (B)(6) 2026 12:14:47 CIU INFORMATION ABL CATHETER LOADING' (B)(6) 2026 12:14:51 RFG WARNING TEMPERATURE ACQUISITION CIRCUIT FAILURE' (B)(6) 2026 12:14:51 RFG INFORMATION TEMPERATURE ACQUISITION CIRCUIT DEGRADATION' (B)(6) 2026 12:14:56 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:14:57 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:14:58 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:14:59 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:15:28 RFG CRITICAL PUMP HARDWARE FAULT' (B)(6) 2026 12:15:29 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:15:35 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:15:41 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:15:44 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:15:50 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2026 12:16:20 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:16:22 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 12:38:33 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:38:33 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 12:38:44 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 13:04:04 RFG WARNING RETURNS 1,4 CURRENT BALANCING FAULT' (B)(6) 2026 13:05:41 RFG WARNING RF OUTPUT ERROR' (B)(6) 2026 13:06:16 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 13:15:31 RFG WARNING RF OUTPUT ERROR' (B)(6) 2026 13:38:40 RFG WARNING TEMPERATURE ACQUISITION CIRCUIT FAILURE' (B)(6) 2026 13:46:29 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 13:47:05 RFG CRITICAL PUMP HOUSING OPEN' (B)(6) 2026 13:47:05 RFG CRITICAL PUMP STOPPED' (B)(6) 2026 13:47:36 RFG WARNING ABL CATHETER NOT CONNECTED' (B)(6) 2026 13:47:36 RFG WARNING CATHETER REFERENCE TEMP TOO LOW' (B)(6) 2026 13:47:36 RFG CRITICAL CATHETER TEMPERATURE SENSOR FAULT' (B)(6) 2026 13:47:36 CIU WARNING ABL CATHETER NOT CONNECTED TO HEXAMAP\XE2\X84\XA2' (B)(6) 2026 13:54:28 CRITICAL DATA SAVE FAULT' (B)(6) 2026 13:54:30 CIU CRITICAL PACING COMMUNICATIONS FAILURE' (B)(6) 2026 13:55:07 WARNING VIDEO NOT SAVED' (B)(6) 2026 13:55:09 CIU WARNING MAGNETIC TRACKING INITIALIZING' (B)(6) 2026 13:58:09 RFG CRITICAL RETURN 1 CONTACT QUALITY POOR' (B)(6) 2026 13:58:09 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 13:58:11 RFG WARNING RETURN 2 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 13:58:12 RFG WARNING RETURN 3 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 13:58:12 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 14:29:40 CIU WARNING MAGNETIC TRACKING INITIALIZING' (B)(6) 2026 14:29:50 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2026 14:29:52 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2026 14:29:58 CRITICAL DATA SAVE FAULT' (B)(6) 2026 14:30:00 CIU CRITICAL PACING COMMUNICATIONS FAILURE' (B)(6) 2026 14:30:06 CIU WARNING MAGNETIC TRACKING INITIALIZING' (B)(6) 2026 14:30:37 WARNING VIDEO NOT SAVED' (B)(6) 2026 14:31:41 CIU WARNING MAGNETIC TRACKING INITIALIZING' (B)(6) 2026 14:31:52 WARNING LOCATION REFERENCE NOT CALIBRATED' (B)(6) 2026 14:31:54 CRITICAL NO LOCATION PATCHES DETECTED' (B)(6) 2026 14:35:38 CRITICAL NO ANTERIOR PATCH DETECTED' (B)(6) 2026 14:51:05 RFG CRITICAL REMOTE CONTROL IS IN USE BUT IS INCOMPATIBLE!' (B)(6) 2026 14:51:05 RFG INFORMATION ABL REMOTE CONTROL CONNECTING' (B)(6) 2026 14:51:05 RFG INFORMATION ABL REMOTE CONTROL OFFLINE' (B)(6) 2026 14:51:05 RFG CRITICAL REMOTE CONTROL IS IN USE BUT OFFLINE!' (B)(6) 2026 14:51:20 RFG INFORMATION REMOTE HIGH CPU USAGE' (B)(6) 2026 14:51:23 RFG INFORMATION ABL REMOTE CONTROL CONNECTING' (B)(6) 2026 15:17:37 RFG CRITICAL RETURN 1 CONTACT QUALITY POOR' (B)(6) 2026 15:17:37 RFG WARNING RETURN 1 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 15:18:03 RFG CRITICAL RETURN 4 CONTACT QUALITY POOR' (B)(6) 2026 15:18:03 RFG WARNING RETURN 4 CQM IMPEDANCE 40% INCREASE' (B)(6) 2026 15:27:02 CIU INFORMATION ABL CATHETER LOADING' (B)(6) 2026 15:27:33 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 15:27:45 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 15:27:50 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 15:27:55 RFG CRITICAL CATHETER PREP. SEQUENCE RUNNING' (B)(6) 2026 15:28:25 RFG CRITICAL PUMP PURGE ACTIVE' (B)(6) 2026 15:57:18 RFG WARNING PATIENT TEMPERATURE TOO HIGH' (B)(6) 2026 16:05:32 RFG WARNING RF OUTPUT ERROR' (B)(6) 2026 16:19:04 INFORMATION GENERATOR IS OFFLINE' (B)(6) 2026 16:19:04 INFORMATION CIU IS OFFLINE' (B)(6) 2026 16:19:30 CRITICAL DATA SAVE FAULT' IN CONCLUSION, THE REPORTED 'LV THRESHOLD INCREASED' IS PLAUSIBLE BASED ON DATA ANALYSIS. THE PHYSICAL PRODUCT WAS NOT RECEIVED. 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 AFTER A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE USING THE AFFERA SYSTEM, THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS REPROGRAMMED, AND IT WAS OBSERVED THAT THE LEFT VENTRICULAR LEAD PACING THRESHOLD HAD INCREASED FROM 1.2V/0.4MS PRE-PROCEDURE TO 2.7V/0.4MS POST-PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, REMAINED IN RECOVERY WITH AN OVERNIGHT STAY SCHEDULED, AND THRESHOLDS WERE PLANNED TO BE CHECKED AGAIN DURING RECOVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117089 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1