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 performance with the device is affected.The user's parents reported that the user had a sudden loss of benefit with the device at the end of (b)(6) 2021.

Manufacturer Narrative

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

Event Description

The user_s performance with the device is affected.The user's parents reported that the user had a sudden loss of benefit with the device at the end of (b)(6) 2021.The user has been re-implanted.

Event Description

The user performance with the device is affected.The user's parents reported that the user had a sudden loss of benefit with the device at the end of (b)(6) 2021.

Manufacturer Narrative

Additional information: according to currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However, a device investigation is necessary to determine a root cause.Re-implantation is considered but no date has been scheduled yet.

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

Event Description

The user_s performance with the device is affected.The user's parents reported that the user had a sudden loss of benefit with the device at the end of (b)(6) 2021.The user 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
• MDR Report Key: 11775304
• MDR Text Key: 248997521
• Report Number: 9710014-2021-00329
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737088422
• UDI-Public: (01)09008737088422
• 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,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 09/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR