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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
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
The replacement surgery was scheduled for (b)(6) 2025, but due to severe inflammation, the replacement was abandoned.Only the electrode was removed, and an insertion electrode (medium) was inserted.According to the doctor, it is suspected that the lead may have touched the eardrum, causing inflammation and subsequently leading to cholesteatoma.During surgery, only the electrode lead was removed, and a dummy electrode was inserted.The housing was preserved.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field explantation was planned due to a migration of the electrode out of cochlea.During revision surgery only the electrode was explanted due to an inflammation and cholesteatoma.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.However, the presence of the device might have contributed to its subsequent development.Further in situ measurements showed two channels involved in a short circuit due to undetermined reasons.This is a final report.
Event or Problem Description
The replacement surgery was scheduled for (b)(6) 2025, but due to severe inflammation, the replacement was abandoned.Only the electrode was removed, and an insertion electrode (medium) was inserted.According to the doctor, it is suspected that the lead may have touched the eardrum, causing inflammation and subsequently leading to cholesteatoma.During surgery, only the electrode lead was removed, and a dummy electrode was inserted.The housing was preserved.

• 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: 24080091
• Report Number: 9710014-2026-00031
• Device Sequence Number: 5828081
• Product Code: MCM
• UDI-Device Identifier: 09008737094058
• UDI-Public: (01)09008737094058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/11/2022
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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: 82 YR
• Patient Sex: Female