inforMED
MalfunctionMXC

ASSERT-IQ¿ ICM

Received Jul 22, 2026 · Event occurred Jul 2, 2026

Report 2017865-2026-15367 · MDR key 25902008

Device

Generic name

Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

Model number

DM5500

Lot number

S000104457

Product problems

  • Under-Sensing

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSION SHOWED THAT THE IMPLANTABLE CARDIAC MONITOR EXHIBITED UNDER-SENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.