CPR4
Received May 7, 2025 · Event occurred Apr 11, 2025
Report 1000165971-2025-00332 · MDR key 21974565
Device
Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTEDLY, CPR4 NO LONGER HAD ANY DATA TRANSMISSION OR LIGHT SIGNALS DURING FOLLOW-UP.
Additional Manufacturer Narrative
THE REVIEW OF PROVIDED DATA CONFIRMED THE REPORTED ISSUE ON 11 APRIL 2025; THE DEVICE COULD NOT BE INTERROGATED BECAUSE OF RECURRENT COMMUNICATION ISSUES. THE MOST LIKELY HYPOTHESIS TO EXPLAIN THE REPORTED ISSUE IS THAT TOO MUCH ELECTROMAGNETIC INTERFERENCES WERE PRESENT DURING THE PACEMAKER INTERROGATION SUCH AS NEARBY SCREENS, LAPTOPS CHARGERS, ELECTROPHYSIOLOGY MAGNETIC SENSORS OR OTHER TELEMETRY HEADS LEADING TO THE IMPOSSIBILITY TO INTERROGATE THE PACEMAKER. IT IS RECOMMENDED TO AVOID AS MUCH AS POSSIBLE NOISY ENVIRONMENT NEARBY THE TELEMETRY HEAD WHILE A DEVICE IS INTERROGATED. NO GENERAL MALFUNCTION IS SUSPECTED ON THE SUBJECT DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.
Description of Event or Problem
REPORTEDLY, CPR4 NO LONGER HAD ANY DATA TRANSMISSION OR LIGHT SIGNALS DURING FOLLOW-UP.