CapSureFix Novus Lead MRI SureScan
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 3008973940-2026-05732 · MDR key 50096014
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Medtronic Singapore OperationsModel number
5076-58Catalog number
5076-58
Product problems
- Break
- Low impedance
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the Right Ventricular (RV) lead exhibited low impedance. It was further reported that the low impedance was due to "suspected lead wear". The RV lead was reprogrammed, explanted and replaced. 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.