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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Impedance Problem (2950); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
The user mother reported that the user had a regional erythema three days after a trauma over the device region.The erythema lasted approximately three days.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should 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 users mother reported that the user had a regional erythema three days after a trauma over the device region.It is unknown if the users hearing perception is affected.Further medical intervention is considered; however, no decision has been made.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.Further the recipient suffered from an erythrema at th implant site likely caused by the reported impact.However, to confirm an exact root cause device investigation would be necessary.No information on possible further steps has been received.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.Furthermore, the recipient suffered from an erythema at the implant site likely caused by the reported impact.However, to confirm an exact root cause 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 mother reported that the user had a regional erythema three days after a trauma over the device region.It was unknown if the user_s hearing perception was affected.The user has been 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: 15455353
• Report Number: 9710014-2022-00693
• Device Sequence Number: 20548874
• Product Code: MCM
• UDI-Device Identifier: 09008737062712
• UDI-Public: (01)09008737062712
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 10/05/2023

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 Expiration Date: 08/26/2023
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 09/19/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 12/13/2022; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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: 4 YR
• Patient Sex: Female