CONCERTO
Received Jan 19, 2026 · Event occurred Dec 15, 2025
Report 9710014-2026-00037 · MDR key 24108431
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
- Insufficient Device Problem Information
Patient
5 YR · Male
- Insufficient Information
- 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 HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: BASED ON THE AVAILABLE INFORMATION FROM THE FIELD, A DAMAGE TO THE REFERENCE ELECTRODE SEEMS LIKELY. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE, DEVICE INVESTIGATION AT THE EXPLANTED DEVICE WOULD BE NECESSARY. RE-IMPLANTATION IS CONSIDERED, BUT NO EXACT DATE HAS BEEN SCHEDULED YET.
Description of Event or Problem
THE USER'S MOTHER NOTICED A DECREASE IN REACTION TO SOUNDS OVER THE COURSE OF SEVERAL MONTHS. THE USER WILL BE RE-IMPLANTED. NO DATE HAS BEEN SCHEDULED YET.