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

Model Number	AFR-00003
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	06/02/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a 'ciu offline' notification occurred with the catheter interface unit (ciu) prior to use during setup for a procedure, resulting in no lights on the ciu and the procedure being aborted while the patient was under general anesthesia before electrophysiology access was obtained.The case was cancelled.Multiple troubleshooting steps were performed, including rebooting the system multiple times, swapping fiber and ethernet cables and ports, running an ethernet cable from the ciu to the workstation, changing presets on the radiofrequency (rf) generator to check communication, and conducting electrical safety and field service tests on the system.Technical services recommended replacement of the ciu.The catheter interface unit was replaced, and the system was installed and tested, with electrical safety and field service tests performed.No uncorrectable faults were noted, and the system was deemed ready for service.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the mapping system was returned and analyzed.The catheter interface unit (ciu) was replaced due receipt of the "ciu offline" notification.Electrical safety and field service testing was performed in accordance with established procedures.In conclusion, the mapping catheter failed the returned product inspection due to the ciu offline notification.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: 22346632
• Report Number: 3012520654-2025-00078
• Device Sequence Number: 8527004
• Product Code: DQK
• UDI-Device Identifier: 00763000871956
• UDI-Public: (01)00763000871956(11)250320(21)A62533201
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K233943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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-00003
• Device Catalogue Number: AFR-00003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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