CapSureFix Novus Lead MRI SureScan
Received Jul 31, 2026 · Event occurred Jul 11, 2026
Report 2649622-2026-22636 · MDR key 50095809
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Medtronic Puerto Rico VillalbaModel number
5076-52Catalog number
5076-52
Product problems
- Pacing Problem
- Under-Sensing
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress, with inappropriate pacing noted at times. The Right Ventricular (RV) lead exhibited undersensing resulting in inappropriate pacing. The RA and RV leads remain in use. 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.