CONCERTO
Received Feb 4, 2026 · Event occurred Jan 28, 2026
Report 9710014-2026-00110 · MDR key 24256834
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
Patient
72 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO A DEFECTIVE ELECTRODE. THE USER WAS RE-IMPLANTED.
Additional Manufacturer Narrative
CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE WHICH IS CONSISTENT WITH MINUTE DEVICE MOBILITY WAS DETERMINED TO HAVE LED TO DEVICE FAILURE OVER TIME DUE TO FATIGUE WIRE BREAKAGES. THE PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.
Description of Event or Problem
THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO A DEFECTIVE ELECTRODE.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO MED-EL HQ WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.