CONCERTO
Received Apr 30, 2026 · Event occurred Dec 28, 2025
Report 9710014-2026-00408 · MDR key 25044216
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
Patient
4 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CONCLUSION: BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE ACTIVE ELECTRODE DUE TO EXCESSIVE MECHANICAL STRESS SEEMS VERY LIKELY. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE DEVICE INVESTIGATION WOULD BE NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.
Description of Event or Problem
THE USER EXPERIENCED A SUDDEN LOSS OF HEARING SENSATION STARTING ON (B)(6) 2025. 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
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.