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	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user's hearing performance with the device is affected.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode due to an external mechanical impact appears to be likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.No information on possible further steps has been received.
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's hearing performance with the device is affected.There was a sudden loss of hearing.Reportedly someone informed the mother that the child had a fall, but the mother herself did not observe any trauma.Prior to the event the hearing perception and language development were fine.No change in medication, no significant medical history, no redness or swelling, no infection and no pain at the implant site were reported.Further proceedings are unknown at this time.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode due to an external mechanical impact appears to be likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user's hearing performance with the device is affected.The user's hearing performance with the device is affected.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: 21545414
• Report Number: 9710014-2025-00225
• Device Sequence Number: 18064297
• 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: 2023
• 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: 04/11/2025
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 03/04/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/07/2025; 12/16/2025
• Date Device Manufactured: 04/11/2022
• 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: 5 YR
• Patient Sex: Male