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 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 hearing performance with the device is affected and in situ testing showed affected channels.Ct scan is considered to check if the electrode is inside the cochlear.

Manufacturer Narrative

Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.No information on possible further steps has been received.

Event Description

The hearing performance with the device was affected and in situ testing showed affected channels.The clinic will discuss how to proceed.

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 Description

The hearing performance with the device was affected and in situ testing showed affected channels.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: 16041815
• MDR Text Key: 306413409
• Report Number: 9710014-2022-00987
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049119
• UDI-Public: (01)09008737049119
• 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: 01/17/2024

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: 06/14/2020
• 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: 03/14/2023; 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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: 9 YR
• Patient Sex: Male