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

Model Number MI1000 MED-EL CONCERT

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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

The user's mother reported that the child's hearing performance with the device is affected in the last ten days.

Manufacturer Narrative

Conclusion: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.Further information on the implant registration card states that one channel was left extra-cochlear at implantation surgery.In addition 2-3 channels migrated post-operatively out of cochlea as confirmed by diagnostic imaging.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.

Event Description

The recipient_s mother reported that the child_s hearing performance with the device gradually started to worsen in the previous ten days.She also reported that there was still residual hearing perception.The child is suffering from imbalance problems that started one year before implantation; therefore, it is not known if an accident happened.Currently, there is no medical issue identified related with this imbalance problem.No recent changes in health or medication have been reported.It was decided to proceed with a re-implantation, however a date for the surgery has not been scheduled yet.

Event Description

The recipients mother reported that the childs hearing performance with the device gradually started to worsen in the previous ten days.She also reported that there was still residual hearing perception.The recipient has been re-implanted on the (b)(6) 2021.

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.Further information on the implant registration card states that one channel was left extra-cochlear at implantation surgery.In addition 2-3 channels migrated post-operatively out of cochlea as confirmed by diagnostic imaging.The problems given in the recipient report appear to match the damage found.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
• MDR Report Key: 10640550
• MDR Text Key: 210168292
• Report Number: 9710014-2020-00574
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737083632
• UDI-Public: (01)09008737083632
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2021
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 08842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR