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

Model Number	SONATA
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/19/2023
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
On (b)(6) 2022 the rehabilitation center reported that the user might have had a trauma.In situ testing showed affected channels and poor hearing performance with the device.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusion: the investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.Other damages found during device investigation are most likely related to the explantation surgery.This is a final report.
Event or Problem Description
On 11-dec-2022 the rehabilitation center reported that the user might have had a trauma.In situ testing showed affected channels and poor hearing performance with the device.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: 16288758
• Report Number: 9710014-2023-00094
• Device Sequence Number: 12458794
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 03/14/2023

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: 03/25/2022
• Device Model Number: SONATA
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male