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 is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

Family referred inconsistent responses, sometimes the patient responded better to auditory stimulus, sometimes no responses at all.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.However to confirm an exact root cause of failure a device investigation of the explanted device is necessary.No date for revision surgery has been communicated yet.

Event Description

The user's hearing performance with the device is affected.Re-implantation has been recommend, though has not been decided upon yet.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.

Event Description

The recipient's hearing performance with the device is affected.The recipient has been re-implanted.

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 active electrode also showed some additional damage to the electrode wires, as being caused by minute device mobility.An accident or impact might have weakened the fixation of the implant, consequently leading to electrode mobility.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The recipient's hearing performance with the device is affected.The recipient 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: 10598073
• MDR Text Key: 208930545
• Report Number: 9710014-2020-00522
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083618
• UDI-Public: (01)09008737083618
• 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,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/17/2018
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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: 7 YR
• Patient Sex: Female