Medtronic CRT
Received Jul 31, 2026 · Event occurred Jul 7, 2026
Report 2182208-2026-47169 · MDR key 50094205
Device
Generic name
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronizatio
Manufacturer
Medtronic, Inc.Model number
MDT-CRTCatalog number
MDT-CRT
Product problems
- Capturing Problem
Patient
Not reported
- Non specific EKG/ECG Changes
Narrative
Description of Event or Problem
It was reported that there was a pause reported on telemetry. It was noted that the cause of the pause was likely due to the device feature that monitors the pacing amplitude threshold and adjusts the Left Ventricular (LV) output, but it was not definitive. The Cardiac Resynchronization Therapy Device remains in use. 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.