MalfunctionDTB
PERMANENT PACEMAKER ELECTRODE
Received Dec 11, 2024
Report MW5163486 · MDR key 20912525
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Medtronic Singapore Operations Pte Ltd.Model number
5568Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED JUMPY HIGH OUT OF RANGE PACING IMPEDANCE. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND ADVISED TROUBLESHOOTING ACTIONS. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).