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

Model Number	MI1260 SONATA 2
Medical Device Problem Codes	Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Due to a migration, the hospital had to gradually deactivate channels over time which started in (b)(6) 2023.Which led to only three electrodes functioning, resulting in no benefit for the recipient.The recipient has been explanted and re-implanted with a device from another manufacturer.
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.
Additional Manufacturer Narrative
Conclusion: based on the information received from the field, the recipient had a decrease in hearing benefit.Further, according to the device explanation report form three channels were observed out of cochlea and the electrode lead was found extruded.Device investigation revealed that damage to the active electrode which is consistent with minute device mobility led to device failure over time due to fatigue wire breakages, possibly resulting from electrode movement from its original position.Also, fibrotic tissue in the posterior tympanotomy and surrounding the electrode have been observed, which might have contributed to the electrode displacement.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.Reportedly, the user had only 3 functioning channels, as channels have been gradually deactivated over time, starting in december 2023.The user has been explanted and re-implanted with a new device from another manufacturer.

• 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: 18892555
• Report Number: 9710014-2024-00231
• Device Sequence Number: 15374241
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 05/21/2024

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: 07/26/2025
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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: 27 YR
• Patient Sex: Female