MAUDE Adverse Event Report: MEDTRONIC, INC. ACCURHYTHM ZA410 (AF); RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)

Model Number	ZA410
Medical Device Problem Code	Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a company representative that patient was in clinic and the physician saw an atrial fibrillation (af) episode that had been adjudicated as false by the artificial intelligence (ai) algorithm when the physician believes that one of the episodes was a true af episode.The physician was concerned about the possibility of not seeing an af episode due to the patient having had a previous stroke.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
No data 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
A supplemental report is being submitted for correction and investigation completion.Correction: e.Facility name, street 1, city, region, postal code product event summary: the artificial intelligence (ai) algorithm is still in use.No product or clinical data was received for evaluation.It was confirmed with the technical services that the company representative did not offer which atrial fibrillation (af) episode they were referring to and they could not confirm the date the reported event happened.Contributing factors that can lead to this event are documented in the risk management file.This event was foreseen in risk management and is included in monitoring; therefore no further investigation was required.There was no indication that the event was related to a possible manufacturing issue, therefore no device history record review was performed.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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: ACCURHYTHM ZA410 (AF)
• Common Device Name: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20916084
• Report Number: 2182208-2024-05273
• Device Sequence Number: 19614305
• Product Code: MXD
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZA410
• Device Catalogue Number: ZA410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LNQ22.
• Patient Age: 62 YR
• Patient Sex: Male