MalfunctionMCM
CONCERTO
Received Apr 16, 2026 · Event occurred Apr 1, 2026
Report 9710014-2026-00361 · MDR key 24903375
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Circuit Failure
Patient
3 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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
THE USER EXPERIENCED A SUDDEN LOSS OF HEARING SENSATION. RE-IMPLANTATION IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.