MAUDE Adverse Event Report: MEDTRONIC, INC. AFFERA; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	AFR-00004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id afr-00008 (unknown serial/lot); product type: 3294-generator.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.
Event or Problem Description
It was reported that during use, temperature-related failures involving catheter temperature sensor fault and catheter reference temperature low errors occurred.The generator link cables were noted to appear compressed and possibly damaged prior to the case.Multiple troubleshooting steps were performed, including full system reboots in different sequences, reconnection of the catheter, replacement of the catheter extension cable and catheter, and reorientation of the generator link cables.Despite these efforts, the errors persisted.The procedure was aborted while the patient was under general anesthesia.Technical services requested replacement generator link cables and a return electrode adaptor.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: non-medtronic product type: intracardiac echocardiography (ice) catheter product id: non-medtronic product type: catheter product id: non-medtronic product type: sheath product id: non-medtronic product type: sheath product id: afr-00001 product type: catheter.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.
Event or Problem Description
It was further reported that pulsed field ablations were being utilized around the left pulmonary veins.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The log files returned from the field were viewed using the log file analysis tool.The reported "catheter reference temp too low" and "catheter temperature sensor fault" were confirmed through data analysis.The radiofrequency generator (rfg) is still in use.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.

• Brand Name: AFFERA
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer (Section G): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23017142
• Report Number: 3012520654-2025-00134
• Device Sequence Number: 21249021
• Product Code: DQK
• UDI-Device Identifier: 00763000871864
• UDI-Public: (01)00763000871864(11)250521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P240013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AFR-00004
• Device Catalogue Number: AFR-00004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 02/09/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 12/08/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown