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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user came for a follow-up visit on (b)(6) 2025, because he could not hear from his right ear.The family reported that he hit his head on (b)(6) 2025 and a few days later, when the external device was on his head, the red light kept flashing.Therefore the external device was not used any longer.There was no swelling or redness over the implant area.The external equipment was checked.Re-implantation is being considered, but no date has been scheduled yet.
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.Re-implantation is being considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: based on the information and measurements received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.Further, in situ measurements before the reported impact show one channel with high impedance due to undetermined reasons.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.

• 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: 21932650
• Report Number: 9710014-2025-00382
• Device Sequence Number: 8907461
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 11/07/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 11/07/2019
• 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: 8 YR
• Patient Sex: Male