MalfunctionMXC
CONFIRM
Received Jan 28, 2026 · Event occurred Jan 7, 2026
Report 2017865-2026-01679 · MDR key 24205567
Device
Generic name
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Manufacturer
St. Jude Medical, Inc.(crm-sylmar)Model number
DM3500Lot number
P000207728
Product problems
- Insufficient Device Problem Information
- Interrogation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT'S INSERTABLE CARDIAC MONITOR WAS UNABLE TO SEND A REMOTE TRANSMISSION DUE TO UNSPECIFIED OUT OF RANGE PARAMETERS. IN THE FOLLOWING DAYS, ANOTHER TRANSMISSION WAS SUCCESSFULLY SENT AND PARAMETERS SHOWED WITHIN NORMAL LIMITS. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.