Affera

Description of Event or Problem

It was reported that during a cardiac ablation procedure, intermittent internal communication error occurred and the catheter was not recognized by the mapping system. It was reported that these issues occured on two mapping systems. Multiple catheters and extension cables from different lot numberes were tried, the mapping system and workstation were rebooted, but the issue persisted. The case was aborted. It is unknown if the patient was under general anesthesia. Attempts were made to reproduce the issue in another room and in a wet lab with the same catheter and cable, but could not be reproduced. It was also reported that the most common issue is in the site was severe local impedance. Rebooting the system may temporarily resolve it, but it occured in nearly every case. No further 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.