MalfunctionDTB
PERMANENT PACEMAKER ELECTRODE
Received May 11, 2026
Report MW5188002 · MDR key 25148087
Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY CAPPED DUE TO PRODUCT PERFORMANCE ISSUE. SUBSEQUENTLY, A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).