MalfunctionDTB
PERMANENT PACEMAKER ELECTRODE
Received Jun 4, 2026
Report MW5188997 · MDR key 25406774
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
St. Jude Medical/abbott MedicalModel number
1688TCPatient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).