MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH COMBI C40; COCHLEAR IMPLANT

Model Number	C40+
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The user reported sudden hearing loss in the right ci.Re-implantation was performed.
Additional Manufacturer Narrative
Additional information: according to the complaint information and the manufacturer_s experience with this kind of device, it is assumed that the device might have failed due to humidity ingress at the housing braze joint through micro-leaks.However to determine an exact root cause of failure a device investigation of the explanted device would be necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user reported sudden hearing loss in the right ci.Re-implantation was performed.
Additional Manufacturer Narrative
Conclusion: device investigation confirmed that the stimulator electronics is not working according to specifications.Based on the manufacturer_s experience with this kind of devices, it can be assumed that the device has failed due to loss of hermeticity at the housing braze joint.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user reported sudden hearing loss in the right ci.Re-implantation was performed.

• Brand Name: COMBI C40
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 24255409
• Report Number: 9710014-2026-00105
• Device Sequence Number: 15945336
• Product Code: MCM
• UDI-Device Identifier: 09008737082550
• UDI-Public: (01)09008737082550
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: C40+
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026; 02/02/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/05/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male