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 12/25/2021

Event Type  malfunction  

Event Description

The user's hearing performance with the device is affected.The parents reported that the user shows poor response to name calling and verbal requests.Measurements would show multiple channels with abnormal impedances.

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.

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.Re-implantation is considered but no date has been scheduled yet.

Event Description

The user's hearing performance with the device is affected.The parents reported that the user shows poor response to his name being called and verbal requests.Re-implantation is considered.

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.The concerned device was explanted but has not been received for investigation yet.

Event Description

The user's hearing performance with the device is affected.The parents reported that the user shows poor response to his name being called and verbal requests.The user was re-implanted.

Manufacturer Narrative

Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue breakages.The problems given in the recipient report appear to match the damage found.Other observed damages are most likely attributable to the explantation surgery.This is a final report.

Event Description

The user's hearing performance with the device is affected.The parents reported that the user shows poor response to his name being called and verbal requests.The user was 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: 13092078
• MDR Text Key: 283435259
• Report Number: 9710014-2021-01071
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 07/26/2023

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: 10/27/2017
• Device Model Number: SONATA
• Device Catalogue Number: 04917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 12/25/2021; 12/25/2021; 12/25/2021
• Supplement Dates FDA Received: 02/25/2022; 04/12/2022; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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: 10 YR
• Patient Sex: Male