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

Model Number MI1000 MED-EL CONCERT

Device Problem Impedance Problem (2950)

Patient Problems Ossification (1428); Failure of Implant (1924)

Event Date 06/22/2023

Event Type  malfunction  

Event Description

The user had some problems with hearing on the right side for several years.The clinic is considering a ct-scan or mri and re-implantation as the next steps.

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 some problems with hearing on the right side for several years.The user has been re-implanted.

Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation has been carried out but the device has not been received for investigation purposes yet.

Event Description

The user had some problems with her hearing on the right side for several years.Some channels were deactivated but she still had good audiological outcomes, so no intervention was done at that time.Additional channels were deactivated and the benefit decreased.The user has been re-implanted with a new device.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device damage or defect which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.Based on the available information the cause for the observed performance issues leading to the explantation is likely related to the cochlea's physiology.The implant registration card of the new device points to an unexpected ossification, which would explain the reported issue.This is a final report.

• 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: 17206663
• MDR Text Key: 317922555
• Report Number: 9710014-2023-00539
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083632
• UDI-Public: (01)09008737083632
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2015
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 08842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: Female