CONCERTO
Received Dec 30, 2025 · Event occurred May 21, 2025
Report 9710014-2025-01233 · MDR key 23920305
Device
Generic name
Cochlear Implant
Manufacturer
Med-el Elektromedizinische Geraete GmbhModel number
MI1000 MED-EL CONCERT PINProduct problems
- Circuit Failure
- Circuit Failure
Patient
31 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER COMPLAINED OF DISSATISFACTION DUE TO SIGNIFICANTLY LOWER CLARITY SINCE (B)(6) 2024 COMPARED TO THE DEVICE FROM ANOTHER MANUFACTURER ON THE CONTRALATERAL SIDE. THE USER HAS BEEN REIMPLANTED WITH A DEVICE FROM ANOTHER MANUFACTURER.
Additional Manufacturer Narrative
CONCLUSION: DEVICE INVESTIGATION CONFIRMED THAT STIMULATOR ELECTRONICS IS WORKING ACCORDING TO SPECIFICATIONS. HOWEVER, A REDUCED ELECTRICAL IMPEDANCE BETWEEN COIL AND EAP/RG (EVOKED ACTION POTENTIALS/ REMOTE GROUND) ELECTRODE WAS DISCOVERED DURING INVESTIGATION, WHICH VERY LIKELY CAUSED THE REPORTED ISSUES. THIS IS A COMBINED INITIAL+FINAL REPORT.