MalfunctionMXC
Assert-IQ¿ ICM
Received Jul 27, 2026 · Event occurred Jun 30, 2026
Report 2017865-2026-15478 · MDR key 50009560
Device
Generic name
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Manufacturer
Abbott Medical (crm-sylmar)Model number
DM5500Lot number
S000094680
Product problems
- Over-Sensing
Patient
50 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the patient presented via remote transmission. Upon review, the implantable cardiac monitor exhibited noise oversensed episodes that resulted in false atrial fibrillation (AF) episodes. No intervention was performed. There was no patient consequences reported.