inforMED
InjuryMXC

Assert-IQ¿ ICM

Received Jul 27, 2026 · Event occurred Jun 1, 2026

Report 2017865-2026-15473 · MDR key 50009301

Device

Generic name

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

Model number

DM5500

Lot number

S000098307

Product problems

  • Unexpected Mode Switch

Patient

51 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that the patient presented in clinic for a follow up. Upon interrogation, the implantable cardiac monitor (ICM) was in back-up mode. The ICM was explanted and replaced. No patient consequences reported.