CONCERTO
Received Dec 19, 2025 · Event occurred Dec 18, 2025
Report 9710014-2025-01202 · MDR key 23848466
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
- Impedance Problem
Patient
72 YR · Female
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- 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. RE-IMPLANTATION IS BEING CONSIDERED BUT THE CURRENT CONDITION OF THE COCHLEA IS UNCERTAIN.
Description of Event or Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED BUT THE CURRENT CONDITION OF THE COCHLEA IS UNCERTAIN.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY IS SUSPECTED. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.