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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Impedance Problem (2950); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Head Injury (1879); Failure of Implant (1924)
Date of Event	08/06/2024
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's hearing performance with the device is reportedly affected due to a trauma to the head that occured on (b)(6) 2024.
Additional Manufacturer Narrative
Based on the received information, a damage to the active electrode due to the reported mechanical impact appears very likely.However, to determine an exact root cause device investigation would be necessary.No information on possible further steps has been received.
Event or Problem Description
The user's hearing performance with the device is affected due to a trauma to the head that occurred on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported mechanical impact appears very likely.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's hearing performance with the device is affected after a trauma to the head that occurred on (b)(6) 2024.The user has been re-implanted.

• 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: 20143364
• Report Number: 9710014-2024-00808
• Device Sequence Number: 4209590
• Product Code: MCM
• UDI-Device Identifier: 09008737093952
• UDI-Public: (01)09008737093952
• 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: 2018
• 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,Followup
• Report Date (Section B): 02/13/2025

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: 06/25/2021
• Device Model Number: MI1200 SYNCHRONY
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 08/26/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/16/2024; 02/13/2025
• Date Device Manufactured: 06/25/2018
• 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