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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user has no hearing response on three channels during single channel stimulation.Currently, 10 channels are usable for stimulation; however, channels 7-9 also seem unusable due to no response regardless of the stimulation.Implant check was conducted on (b)(6) 2024.During the appointment 6 channels were deactivated due to insufficient benefit from these, which resulted in lightly better sound quality.A ct scan was planned.The user has been re-implanted on (b)(6) 2025 due to a complete electrode migration out of the cochlea.
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
It was reported that the user has no hearing response on three channels during single channel stimulation.Currently, 10 channels are usable for stimulation; however, channels 7-9 also seem unusable due to no response regardless of the stimulation.Implant check was conducted on (b)(6) 2024.During the appointment 6 channels were deactivated due to insufficient benefit from these, which resulted in lightly better sound quality.A ct scan was planned.The user has been re-implanted on (b)(6) 2025 due to a complete electrode migration out of the cochlea.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the device was not providing benefit due to a migration of the electrode out of cochlea.Further, during device investigation damage to the active electrode due to device minute mobility causing fatigue wire breakages was found.Other mechanical damages are related to the removal surgery.This is a final report.

• Brand Name: SYNCHRONY
• 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: 21430700
• Report Number: 9710014-2025-00178
• Device Sequence Number: 17314465
• Product Code: MCM
• UDI-Device Identifier: 09008737395353
• UDI-Public: (01)09008737395353
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 03/12/2025

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: 04/25/2026
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: 83 YR
• Patient Sex: Female