MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Twitching (2172)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
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 fns is still present with the new device.The clinic is planning to monitor it through mapping in the future.It was reported that the facial nerve was damaged during drilling.The user will be monitored to see if the condition improves.
Event or Problem Description
The fns is still present with the new device.The clinic is planning to monitor it through mapping in the future.It was later reported that the surgeon seems to have touched the facial nerve during the drilling for the re-implantation surgery.The user will be monitored to see if the condition improves.Despite requested, no further information was received.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experiences facial nerve stimulation (fns) whilst using the device.Reportedly the facial nerve was damaged during implantation surgery, which likely led to the reported symptoms.The recipient will be monitored by the clinic.The device remains implanted and in use.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 18228838
• Report Number: 9710014-2023-01070
• Device Sequence Number: 6268828
• Product Code: MCM
• UDI-Device Identifier: 09008737371753
• UDI-Public: (01)09008737371753
• 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
• 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): 03/04/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/12/2026
• Device Model Number: MI1250 SYNCHRONY 2
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/04/2024
• Date Device Manufactured: 03/12/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male