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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
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
Information was initially received in june 2022 that the recipient has no hearing responses with the current device.As of information received on the 4th of july 2022 the user seems to be responding slightly with their devices.However, as of later information the mother reports not seeing any response to sound at home despite data logging showing 8.9 hours as average use of the device.New information received in december 2022 stated that the array is completely extra-cochlear.According to the implant registration card, 5 channels were left extra-cochlear at implantation.The recipient will be followed up in (b)(6) 2023.
Event or Problem Description
Information was initially received in june 2022 that the recipient has no hearing response with the current device.The hearing performance was consistently low despite data logging showing 8.9 hours of average use.In december 2022 it was then reported that the array was completely extra-cochlear.According to the implant registration card, 5 channels were left extra-cochlear at implantation.The user is no longer wearing the external device and will be followed up in march 2023.
Additional Manufacturer Narrative
Additional information: based on the information received from the field, the device is not providing benefit to the recipient.A post-operative ct scan shows the electrode array completely extra-cochlear possibly due to a post-operative active electrode migration out of the cochlea.A full insertion was not achieved at implantation surgery.According to the implant registration card five channels remained extra-cochlear at implantation surgery.The device is currently not in use.The device remains implanted and further monitoring of the contralateral site is planned.

• 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: 16093243
• Report Number: 9710014-2023-00009
• Device Sequence Number: 6645663
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/25/2024
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Patient Age: 18 MO
• Patient Sex: Male