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 Code	Failure of Implant (1924)
Date of Event	12/24/2020
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
When the user came for a regular check-up, in situ testing showed affected channels.Hearing performance with the device is affected.The parents had previously not noticed any change of hearing or behavior at home.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.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 or Problem Description
When the user came for a regular check-up, in situ testing showed affected channels.Hearing performance with the device is affected.The parents had previously not noticed any change of hearing or behavior at home.
Additional 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 breakages.Also, an impact to the head might have weakened the fixation of the active electrode and could also be a factor for electrode mobility.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
When the user came for a regular check-up, in situ testing showed affected channels.Hearing performance with the device is affected.The parents had previously not noticed any change of hearing or behavior at home.The user was re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 11085585
• Report Number: 9710014-2020-00789
• Device Sequence Number: 2681388
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2022

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: 01/03/2022
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2020
• Supplement Date Received by Manufacturer: 12/26/2020; 12/26/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/08/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male