MalfunctionMCM
CONCERTO
Received Oct 2, 2025 · Event occurred Sep 1, 2025
Report 9710014-2025-00920 · MDR key 23201472
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Impedance Problem
- Impedance Problem
Patient
8 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
Additional Manufacturer Narrative
CONCLUSION: BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE ACTIVE ELECTRODE DUE TO AN EXTERNAL MECHANICAL IMPACT APPEARS VERY LIKELY. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE DEVICE INVESTIGATION WOULD BE NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET. THIS IS A COMBINED INITIAL AND FINAL REPORT.