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

Model Number	MI1000 MED-EL CONCERT
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
The user's father reported that after a fall, the user suddenly stopped hearing and responding to speech on the affected side.It was suggested to do not use the processor on that side.
Event or Problem Description
The user's father reported that after a fall, the user suddenly stopped hearing and responding to speech on the affected side.It was suggested to do not use the processor on that side.It is unknown if there will be further medical intervention, however, as per clinical support review, reimplantation is recommended.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress caused by the reported trauma appears very likely.In addition, imaging confirmed one channel being extra-cochlear.It is unknown if the electrode has migrated post-operatively or if one channel remained outside the cochlear since implantation.However, to determine an exact root cause device investigation would be necessary.Re-implantation is recommended but 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 ; 57788
• MDR Report Key: 16263722
• Report Number: 9710014-2023-00083
• Device Sequence Number: 4173941
• Product Code: MCM
• UDI-Device Identifier: 09008737062729
• UDI-Public: (01)09008737062729
• 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): 04/25/2023

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: 11/29/2022
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07672
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2019
• 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
• Patient Age: 5 YR
• Patient Sex: Unknown