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

Model Number	SONATA
Medical Device Problem Codes	Impedance Problem (2950); 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 is to 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 was seen on (b)(6) 2021 for the annual fitting.In situ testing done during this appointment showed all affected channels.At the appointment with the med-el expert on (b)(6) 2021, the audio processor was checked and found to be functioning and previous measurements were confirmed.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress seems very likely.However to determine an exact root cause device investigation would be necessary.No information on possible further steps has been received yet.
Event or Problem Description
The user was seen on (b)(6) 2021 for his annual fitting.In situ testing done during this appointment showed all channels affected with high impedance or short circuits.At the appointment with the med-el expert on (b)(6) 2021, the audio processor was checked and found to be functioning and the previous measurements were confirmed.
Additional Manufacturer Narrative
Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user was seen on (b)(6) 2021 for his annual fitting.In situ testing done during this appointment showed all channels affected with high impedance or short circuits.The user has been re-implanted.

• 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: 12257703
• Report Number: 9710014-2021-00568
• Device Sequence Number: 11680303
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 02/10/2023

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: 09/24/2021
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 07/29/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/08/2021; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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: Male