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

Model Number SONATA

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 10/07/2019

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

Reportedly the user's hearing performance with the device is affected.

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.In addition, a complete active electrode array insertion could not be achieved at implantation, with also a partial post-operative migration observed at explantation, most likely due to medical reasons.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device has been explanted but has not yet been received.

Event Description

Reportedly the user_s hearing performance with the device is affected.The user was explanted on (b)(6) 2020.It was stated in the device explantation report that during explantation 5 channels were found to be extra-cochlear and that due to the present fibrosis, a re-implantation was not possible.The explanted device could not yet be retrieved for investigation.

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.In addition, a complete active electrode array insertion could not be achieved at implantation, with also a partial post-operative migration observed at explantation, most likely due to medical reasons.The problems given in the recipient report appear to match the damage found.This is a final report.

Event Description

Reportedly the user_s hearing performance with the device is affected.The user was explanted on (b)(6) 2020.It was stated in the device explantation report that during explantation 5 channels were found to be extra-cochlear and that due to the present fibrosis, a re-implantation was not possible.

• 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: 10640616
• MDR Text Key: 210167560
• Report Number: 9710014-2020-00563
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2021

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: 03/26/2020
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 MO