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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
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
Approximately one month ago (b)(6) 2023), the user had a head trauma on the contra-lateral side.Despite this, the user continued to use the implant without interruption.One week ago (mid (b)(6) 2023), the user had an otitis infection on the contra-lateral side.The user attended a routine appointment on (b)(6) 2023, reporting no issues with the implant's functionality.During the appointment, an audiologist conducted a free field threshold audiometry test on both sides individually, yielding similar results for each ear: 20db, 20db, 15db, 20db, 15db, 15db, 15db, 15db.
Additional Manufacturer Narrative
Additional information: based on the currently available information, damage to the reference electrode appears to be likely.However, to determine an exact root cause a device investigation of the explanted device would be necessary.Further technical and medical checks are considered but no date has been scheduled yet.
Event or Problem Description
Approximately one month ago (b)(6) 2023), the user had a head trauma on the contra-lateral side.Despite this, the user continued to use the implant without interruption.One week ago (b)(6) 2023), the user had an otitis infection on the contra-lateral side.The user attended a routine appointment on (b)(6) 2023, reporting no issues with the implant's functionality.Further medical intervention was considered.However, further proceedings are unknown.

• 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: 18398073
• Report Number: 9710014-2023-01148
• Device Sequence Number: 16834190
• Product Code: MCM
• UDI-Device Identifier: 09008737331832
• UDI-Public: (01)09008737331832
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 02/13/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/27/2023
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/13/2024
• Date Device Manufactured: 10/27/2020
• 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: 8 YR
• Patient Sex: Male