InjuryMXC
CONFIRM
Received Mar 16, 2026 · Event occurred Feb 11, 2026
Report 2017865-2026-05453 · MDR key 24613362
Device
Generic name
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
DM3500Lot number
P000171777
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
81 YR · Female
- Discomfort
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED. THE INTERROGATION RESULTS INDICATE ELECTIVE REPLACEMENT INDICATOR (ERI) OR END OF LIFE (EOL), THE VISUAL SCREEN AND THE LONGEVITY ASSESSMENT WERE ACCEPTABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED DUE TO PATIENT EXPERIENCE DISCOMFORT. THERE WERE NO PATIENT CONSEQUENCES.