inforMED
MalfunctionGYE

CPR4

Received Feb 11, 2025 · Event occurred Jan 13, 2025

Report 1000165971-2025-00088 · MDR key 21353427

Device

Generic name

Encephalogram Telemetry System

Model number

CPR4 HEAD

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

Additional Manufacturer Narrative

UPON RECEPTION OF THE SUBJECT DEVICE, THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE HEAD WORKS NORMALLY WITH AN ALIZEA AND A PLATINIUM. THE MOST PROBABLE HYPOTHESIS OF THE REPORTED ISSUE IS THAT THE TWO ELECTRONIC CARDS WERE NOT WELL ALIGNED AND CONNECTED DURING THE DEVICE INTERROGATION. SMALL LIGHT MOVEMENT OF THE SUBJECT PRODUCT COULD REALIGN THE ELECTRONIC CARDS TO GET FULL ELECTRONIC CONNECTION. THIS CASE IS RETAINED AND UTILIZED FOR TRENDING PURPOSES.

Description of Event or Problem

REPORTEDLY, IT TOOK TOO MUCH TIME TO FIND AND INTERROGATE THE IMPLANTABLE DEVICE.

Additional Manufacturer Narrative

UPON RECEPTION OF THE SUBJECT DEVICE, THE REPORTED ISSUE COULD NOT REPRODUCED. THE HEAD WORKS NORMALLY WITH AN ALIZEA AND A PLATINIUM. IT IS RECOMMENDED TO NOT INITIATE COMMUNICATION WITH THE HEAD UNTIL ALL 4 BLUE LEDS ARE LIT, OTHERWISE THE HEAD WILL NOT BE PROPERLY POSITIONED TO DETECT THE IMPLANT, AND COMMUNICATION MAY BE INTERRUPTED. AFTER THE FIRST ANALYSIS THERE WAS NO GENERAL MALFUNCTION IS SUSPECTED ON THE DEVICE. AND THE INVESTIGATION ARE STILL ONGOING.

Description of Event or Problem

REPORTEDLY, IT TOOK TOO MUCH TIME TO FIND AND INTERROGATE THE IMPLANTABLE DEVICE.

Additional Manufacturer Narrative

UPON RECEPTION OF THE SUBJECT DEVICE, THE REPORTED ISSUE COULD NOT REPRODUCED. THE HEAD WORKS NORMALLY WITH AN ALIZEA AND A PLATINIUM. IT IS RECOMMENDED TO NOT INITIATE COMMUNICATION WITH THE HEAD UNTIL ALL 4 BLUE LEDS ARE LIT, OTHERWISE THE HEAD WILL NOT BE PROPERLY POSITIONED TO DETECT THE IMPLANT, AND COMMUNICATION MAY BE INTERRUPTED. NO GENERAL MALFUNCTION IS SUSPECTED ON THE DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TRENDING PURPOSES.

Description of Event or Problem

REPORTEDLY, IT TOOK TOO MUCH TIME TO FIND AND INTERROGATE THE IMPLANTABLE DEVICE.