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 Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
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
Affected channels were reported.Re-implantation is considered.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
Affected channels were reported.Re-implantation is considered.No date has been scheduled yet.

• 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 ; +43-(577)88
• MDR Report Key: 17815742
• Report Number: 9710014-2023-00850
• Device Sequence Number: 14992862
• Product Code: MCM
• UDI-Device Identifier: 09008737366193
• UDI-Public: (01)09008737366193
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 07/28/2026

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: 08/08/2025
• Device Model Number: Mi1210 SYNCHRONY ST
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2023
• Supplement Date Received by Manufacturer: 09/24/2023; 09/24/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/12/2023; 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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: 4 YR
• Patient Sex: Male