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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Impedance Problem (2950); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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 user's hearing performance with the device is affected.The user's mother noticed a change in hearing with the device after trauma to the head.Ct imaging will be performed and reimplantation surgery is being considered.
Event or Problem Description
It was reported on 24.May.2022 that approximately 2 months prior the user fell and then the mother noticed that the user was less responsive to sound.Ct imaging will be performed and reimplantation surgery is being considered.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the reference electrode, as it might be caused by an external mechanical impact appears likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the reference electrode, as it might be caused by an external mechanical impact appears likely.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
It was reported on (b)(6) 2022 that approximately 2 months prior the user fell and then the mother noticed that the user was less responsive to sound.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: 14539632
• Report Number: 9710014-2022-00371
• Device Sequence Number: 4956863
• Product Code: MCM
• UDI-Device Identifier: 09008737366179
• UDI-Public: (01)09008737366179
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/12/2023

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: 03/11/2022
• Device Model Number: MI1200 SYNCHRONY
• Device Catalogue Number: 36629
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022; 05/24/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 08/16/2022; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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: 3 YR
• Patient Sex: Female