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

Model Number	AFR-00008
Medical Device Problem Codes	Communication or Transmission Problem (2896); Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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
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.

• 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: 23832228
• Report Number: 3012520654-2025-00233
• Device Sequence Number: 14725913
• Product Code: DQK
• UDI-Device Identifier: 00763000871925
• UDI-Public: (01)00763000871925(11)250908
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P240013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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-00008
• Device Catalogue Number: AFR-00008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided; 04/07/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/17/2025; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown