inforMED
MalfunctionDTB

MEMBRANE EX

Received May 13, 2026

Report MW5188230 · MDR key 25173322

Device

Generic name

Permanent Pacemaker Electrode

Model number

1474T

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PACEMAKER EXHIBITED OVERSENSING DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) WITH NOISY SIGNALS BEING DETECTED ON THE NON-(B)(6) LEAD. THIS WAS CONFIRMED DURING THE PATIENT'S PREVIOUS FOLLOW-UP, LEADING TO THE NON-(B)(6) LEAD BEING DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).