CONFIRM
Received Feb 8, 2026
Report 2017865-2026-02681 · MDR key 24288529
Device
Generic name
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
DM3500Lot number
P000187708
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
43 YR · Female
- Discomfort
Narrative
Additional Manufacturer Narrative
CORRECTION: SECTION D6B - THE CORRECT " DATE OF EXPLANT" SHOULD HAVE BEEN (B)(6) 2025.
Additional Manufacturer Narrative
CORRECTION: SECTION B1 ¿ TYPE OF REPORT "PRODUCT PROBLEM" CHECKBOX SHOULD NOT BE CHECKED.
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED. THE INTERROGATION RESULTS WERE NORMAL AND THE VISUAL SCREEN WAS ACCEPTABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYMPTOMS OF SKIN DISCOMFORT CAUSED BY THE IMPLANTABLE CARDIAC MONITOR (ICM). THE ICM WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.