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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
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
In situ measurements showed fluctuating impedances over time.Hearing performance is reportedly not affected.However, the user has no oral language skills, making it difficult to measure changes in hearing.The mother reported that the user had the flu twice this year, requiring antibiotics.Re-implantation is being considered.
Event or Problem Description
In situ measurements showed fluctuating impedances over time.Hearing performance is reportedly not affected.However, the user has no oral language skills, making it difficult to measure changes in hearing.Re-implantation is being considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, a damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
In situ measurements showed fluctuating impedances over time.Hearing performance was reportedly not affected.However, the user has no oral language skills, making it difficult to measure changes in hearing.The recipient has been re-implanted with a new device.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, a damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
In situ measurements showed fluctuating impedances over time, however, hearing performance was not affected at the time.The user has no oral language skills, making it difficult to measure changes in hearing.The recipient has been re-implanted with a new device.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.Other damages found during device investigation are most likely related to the explantation surgery.This is a final report.

• 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: 20975116
• Report Number: 9710014-2024-01146
• Device Sequence Number: 19882796
• Product Code: MCM
• UDI-Device Identifier: 09008737385392
• UDI-Public: (01)09008737385392
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/21/2025

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: 06/28/2025
• Device Model Number: MI1260 SONATA 2
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/12/2024; 12/12/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/07/2025; 07/09/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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: 3 YR
• Patient Sex: Female