MalfunctionMCM
CONCERTO
Received Apr 29, 2026 · Event occurred Apr 20, 2026
Report 9710014-2026-00402 · MDR key 25026359
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
Patient
47 YR · Female
- Head Injury
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
FOLLOWING AN IMPACT TO THE HEAD ON (B)(6) 2026, THE USER NO LONGER HAD HEARING BENEFIT WITH THE DEVICE. THE USER WILL BE RE-IMPLANTED.