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

Model Number	MI1210 SYNCHRONY ST
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	03/01/2025
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
The user always had a good hearing performance with the device, but suddenly the hearing sensation stopped.No trauma was reported.The user underwent a ct scan which revealed 2-3 extracochlear electrodes.It is assumed that the active electrode slipped a bit out from the cochlea.According to the information on the implant registration card a full insertion was achieved at initial implantation.Re-implantation is being considered.
Event or Problem Description
The user always had a good hearing performance with the device, but suddenly the hearing sensation stopped.Re-implantation is being considered.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.In addition the electrode array partially migrated out of cochlea (2-3 channels) as confirmed by diagnostic imaging.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.In addition the electrode array partially migrated out of cochlea (2-3 channels) as confirmed by diagnostic imaging.However, to determine an exact root cause device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user always had a good hearing performance with the device, but suddenly the hearing sensation stopped.The user was reimplanted.

• 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: 21581833
• Report Number: 9710014-2025-00238
• Device Sequence Number: 9457017
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 12/16/2025

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: 02/01/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 03/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/09/2025; 12/16/2025
• Date Device Manufactured: 02/01/2019
• 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: 6 YR
• Patient Sex: Female