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

Model Number	SONATA
Medical Device Problem Codes	Circuit Failure (1089); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When the user was followed up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signalled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information the recipient keeps atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.Additional measurements performed on 16-oct-2023 have been reviewed by clinical support and it was indicated that the device is no longer working within specifications.Reimplantation is now considered.
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
When the user was followed up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signaled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information, the recipient has atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.Additional measurements performed on (b)(6) 2023 have been reviewed by clinical support and it was indicated that the device is no longer working within specifications.Re-implantation is being considered.
Additional Manufacturer Narrative
Additional information: based on the received in situ measurements from the field, a technical implant failure is likely.In addition, a partial migration of the active electrode is confirmed, which might have contributed to the reported issues in performance.However, to determine an exact root cause an investigation of the explanted device would be necessary.Re-implantation is considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Based on the received in situ measurements from the field, a technical implant failure is likely.In addition, a partial migration of the active electrode is confirmed, which might have contributed to the reported issues in performance.However, to determine an exact root cause an investigation of the explanted device would be necessary.Re-implantation was carried out, but the device has not been received for investigation yet.
Event or Problem Description
When the user was followed up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signaled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information, the recipient has atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.The recipient has been re-implanted.
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.In addition, a partial migration of the active electrode is confirmed, which might have contributed to the reported issues in performance.Other mechanical damages found during investigation are attributable to the explantation surgery.This is a final report.
Event or Problem Description
During a follow up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signaled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information, the recipient has atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.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: 18417225
• Report Number: 9710014-2023-01155
• Device Sequence Number: 7847187
• 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: 2015
• Device Explanted Year: 2024
• 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): 01/14/2026

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 Expiration Date: 07/03/2016
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 12/27/2023; 12/27/2023
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/21/2024; 09/19/2024; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2014
• 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: 11 YR
• Patient Sex: Female