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

Model Number	SONATA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Head Injury (1879); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The user's father reported that the user fell on the side of the implant around the middle of (b)(6) 2020.The user developed a haematoma on the ear.Since then she can no longer hear with the device.The user's hearing performance with the device before the trauma was good.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was 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 or Problem Description
The user's father reported that the user fell on the side of the implant around the middle of (b)(6) 2020.The user developed a haematoma on the ear.Since then she can no longer hear with the device.The user's hearing performance with the device before the trauma was good.
Additional Manufacturer Narrative
Additional information: based on the received information, damage to the active electrode due to the reported trauma appears likely.However, to determine an exact root cause a device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user's father reported that the user fell on the side of the implant around the middle of (b)(6) 2020.The user developed a haematoma on the ear.Since then she can no longer hear with the device.The user's hearing performance with the device before the trauma was good.
Event or Problem Description
The user's father reported that the user fell on the side of the implant around the middle of (b)(6) 2020.The user developed a hematoma on the ear.Since then she can no longer hear with the device.The user's hearing performance with the device before the trauma was good.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears likely.However to determine an exact root cause a device investigation would be necessary.Re-implantation is considered but no date has been confirmed yet.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10113583
• Report Number: 9710014-2020-00284
• Device Sequence Number: 3636995
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 05/29/2020; 05/29/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/03/2020; 08/14/2020; 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR