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

Model Number SONATA

Device Problems Impedance Problem (2950); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 12/20/2022

Event Type  malfunction  

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 Description

The user had suddenly no hearing sensations with the device after a trauma occurred.Further technical checks were scheduled.

Event Description

The user had suddenly no hearing sensations with the device after a trauma occurred.The user has been re-implanted.

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.However, to determine an exact root cause device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.

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.This is a final report.

Event Description

The user had suddenly no hearing sensations with the device after a trauma occurred.The user has been re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 16041468
• MDR Text Key: 306413503
• Report Number: 9710014-2022-00985
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• UDI-Public: (01)09008737083618
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2021
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 12/21/2022
• Supplement Dates FDA Received: 04/12/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male