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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2024
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's hearing performance with the device was affected.The active electrode was found completely out of the cochlea.The recipient has been explanted.A new device could not be implanted due to fibrosis and ossification in the cochlea.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the device was explanted due to a migration of the active electrode out of cochlea.A complete insertion was achieved during implantation surgery.In addition during device investigation damage to the active electrode caused by device minute mobility causing fatigue wir breakages was found.Other mechanical damages are attributable to the removal surgery.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.The device was explanted as the active electrode was found completely out of the cochlea.The recipient has been re-implanted, but the new device could not be correctly inserted into the cochlea due to fibrosis and ossification.

• 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: 20949310
• Report Number: 9710014-2024-01131
• Device Sequence Number: 7705979
• 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: 2024
• 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): 02/10/2025

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: 08/29/2026
• 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
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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