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

Model Number SONATA

Device Problems Circuit Failure (1089); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

When the user was followed up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signalled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information the recipient keeps atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.Additional measurements performed on 16-oct-2023 have been reviewed by clinical support and it was indicated that the device is no longer working within specifications.Reimplantation is now considered.

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

When the user was followed up, it was not possible to visualize esrt responses unlike in previous exams in which responses were recorded on all channels.The neural responses (art) also seemed to have an atypical morphology, and during tests, maestro signaled several times about the compliance/load on the electrodes.These observed changes and a channel with abnormal impedance caught the attention of the implant team.As per additional information, the recipient has atypical neural responses and variations between the outcomes.Reportedly, there is no evolution in oral language development as well as in auditory skills as the recipient only detects sounds.Additional measurements performed on (b)(6) 2023 have been reviewed by clinical support and it was indicated that the device is no longer working within specifications.Re-implantation is being considered.

Manufacturer Narrative

Additional information: based on the received in situ measurements from the field, a technical implant failure is likely.In addition, a partial migration of the active electrode is confirmed, which might have contributed to the reported issues in performance.However, to determine an exact root cause an investigation of the explanted device would be necessary.Re-implantation is considered, but no date has been scheduled yet.

• 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: 18417225
• MDR Text Key: 331625545
• Report Number: 9710014-2023-01155
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• Combination Product (y/n): N
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2016
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Date Device Manufactured: 07/03/2014
• 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 Age: 11 YR
• Patient Sex: Female