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 hearing performance is reportedly affected.

Manufacturer Narrative

Additional information: according to the 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 is considered but no date has been scheduled yet.

Event Description

The hearing performance with the device is reportedly affected.Further medical intervention is considered.

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 problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

The hearing performance with the device is reportedly affected.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
• MDR Report Key: 11698964
• MDR Text Key: 246430543
• Report Number: 9710014-2021-00287
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737076733
• UDI-Public: (01)09008737076733
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR