inforMED
MalfunctionMXC

Assert-IQ¿ ICM

Received Jul 29, 2026 · Event occurred Jul 9, 2026

Report 2017865-2026-15794 · MDR key 50066285

Device

Generic name

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

Model number

DM5500

Lot number

S000100020

Product problems

  • Over-Sensing

Patient

78 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that the patient presented remotely via Merlin.net. It was noted that the implantable cardiac monitor (ICM) exhibited post-sensed T-wave oversensing. No intervention was performed. The patient was in a stable condition.