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

Model Number	SONATA
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The recipient had cardiological problem during the surgery and it was not possible to achieve a full insertion.The recipient reported that he cannot hear well with the right-side device.It was reported that 5 channels were left extra cochlear at implantation.Re-implantation is considered.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a complete insertion of the active electrode was not achieved at implantation surgery due to cardiological problems, which occurred during surgery.Reportedly five channels were extra-cochlear.Further one additional channel migrated post-operatively out of cochlea.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The recipient had cardiological problem during the surgery and it was not possible to achieve a full insertion.The recipient reported that he cannot hear well with the right-side device.It was reported that 5 channels were left extra cochlear at implantation.Re-implantation is considered.
Event or Problem Description
The recipient had cardiological problem during the surgery and it was not possible to achieve a full insertion.The recipient reported that he cannot hear well with the right-side device.It was reported that 5 channels were left extra cochlear at implantation.At explantation, 7 channels were seen extra-cochlear prior to removal.The recipient has been re-implanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a complete insertion of the active electrode was not achieved at implantation surgery due to cardiological problems, which occurred during surgery.Reportedly, five channels were extra-cochlear.Further two additional channels migrated post-operatively out of cochlea.Reportedly, during explantation surgery seven channels were seen extra-cochlear.The concerned device was explanted but has not been received for investigation yet.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field a complete insertion of the active electrode was not achieved at implantation surgery due to cardiological problems, which occurred during surgery.Reportedly five channels were extra-cochlear.Further two additional channels migrated post-operatively out of cochlea.Reportedly during explantation surgery seven channels were seen extra-cochlear.This is a final report.
Event or Problem Description
The recipient had cardiological problem during the surgery and it was not possible to achieve a full insertion.The recipient reported that he cannot hear well with the right-side device.It was reported that 5 channels were left extra cochlear at implantation.At explantation, 7 channels were seen extra-cochlear prior to removal.The recipient has been re-implanted.

• Brand Name: SONATA
• 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: 20949311
• Report Number: 9710014-2024-01132
• Device Sequence Number: 15380005
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 10/16/2025

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 Expiration Date: 10/02/2022
• Device Model Number: SONATA
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 12/13/2024; 12/13/2024
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/21/2025; 05/14/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2019
• 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: 57 YR
• Patient Sex: Male