CONCERTO
Received Dec 17, 2025 · Event occurred Dec 11, 2025
Report 9710014-2025-01182 · MDR key 23829369
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Circuit Failure
- Impedance Problem
- Circuit Failure
- Impedance Problem
Patient
6 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD A TECHNICAL IMPLANT SEEMS LIKELY. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE DEVICE INVESTIGATION OF THE EXPLANTED DEVICE WOULD BE NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.
Description of Event or Problem
THERE WAS A SUDDEN LOSS OF HEARING SENSATION WITH THE DEVICE. RE-IMPLANTATION IS BEING CONSIDERED.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem
SUDDEN LOSS OF HEARING SENSATION WITH THE DEVICE WAS REPORTED ON (B)(6) 2025.