CONCERTO
Received Feb 17, 2026 · Event occurred Dec 11, 2025
Report 9710014-2026-00158 · MDR key 24362430
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
Patient
12 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN EXPLANTED AND 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 DEVICE WAS EXPLANTED.
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. THE CONCERNED DEVICE WAS EXPLANTED BUT HAS NOT BEEN RECEIVED FOR INVESTIGATION YET.
Description of Event or Problem
THE DEVICE WAS EXPLANTED.