MalfunctionMCM
CONCERTO
Received Jun 3, 2026 · Event occurred May 10, 2026
Report 9710014-2026-00506 · MDR key 25371574
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
Patient
9 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
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.