InjuryMXC
CONFIRM
Received Jul 30, 2026
Report 2017865-2026-15610 · MDR key 50078943
Device
Generic name
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Manufacturer
Abbott Medical (crm-sylmar)Model number
DM3500Lot number
P000175326
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Discomfort
Narrative
Description of Event or Problem
It was reported that the patient presented to the clinic due to skin discomfort at the implant site. As a result, the implantable cardiac monitor was explanted. The patient remained stable throughout the procedure.
Additional Manufacturer Narrative
The reported event was Adverse Event Without Identified Device or Use Problem. The device was returned for analysis. Interrogation results were normal, visual screen was acceptable, and preliminary test results were acceptable.