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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Circuit Failure (1089); Output Problem (3005)
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
The user does not have hearing sensation.A re-implantation is considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.However to determine an exact root cause device investigation of the explanted device would be necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user does not have hearing sensation with the device.It is unknown if an accident or trauma occurred.A re-implantation is considered, but no date has been scheduled yet.
Event or Problem Description
The user did not have hearing sensation with the device.It was unknown if an accident or trauma occurred.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed a defective welding joint between feed-through pin and the implant coil.Other mechanical damages found during investigation are very likely related to the removal surgery.The investigation results appear to match the problems mentioned in the user report.This is a final report.

• 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: 15494466
• Report Number: 9710014-2022-00722
• Device Sequence Number: 4971877
• Product Code: MCM
• UDI-Device Identifier: 09008737062736
• UDI-Public: (01)09008737062736
• 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: 2012
• Device Explanted Year: 2023
• 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): 09/12/2023

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: 04/01/2013
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 09/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/04/2022; 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2011
• 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: 11 YR
• Patient Sex: Female