CAPSURE EPICARDIAL LEAD
Received Jul 15, 2026 · Event occurred Mar 10, 2022
Report 2182208-2026-43786 · MDR key 25825719
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Medtronic, Inc.Model number
4968-35Catalog number
4968-35
Product problems
- Failure to Capture
- Over-Sensing
- Under-Sensing
- Unstable Impedance
Patient
44 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PARTIAL ELECTRICAL RESET OCCURRED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AND UNDERSENSING ON ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RA LEAD EXHIBITED LOSS OF CAPTURE AND FLUCTUATING IMPEDANCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
CONTINUATION OF D10: PRODUCT ID: W1DR01 IPG, IMPLANT DATE: (B)(6) 2018. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.