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)
Date of Event	04/04/2023
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
During activation, the user experienced non-auditory sensations.The electrode array needed to be re-inserted on (b)(6) 2023 because it was located outside the cochlea.Further technical checks are scheduled.
Additional Manufacturer Narrative
Additional information: based on the information received from the field, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea.A re-insertion surgery was performed successfully.However two channels had to be disabled due to non-auditory sensations.The device remains implanted and in use.This is a final report.
Event or Problem Description
During activation, the user experienced non-auditory sensations.Imaging confirmed the presence of extra-cochlear channels.A revision surgery took place, and the electrode array was fully re-inserted again on (b)(6) 2023.During initial implantation on (b)(6) 2023 and a full insertion of the array was achieved.The user was activated and is now using her audio processor.Electrodes 11 and 12 had to be disabled because of no auditory perception.Apart from that, everything is fine.

• 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: 16723425
• Report Number: 9710014-2023-00302
• Device Sequence Number: 15441243
• Product Code: MCM
• UDI-Device Identifier: 09008737366803
• UDI-Public: (01)09008737366803
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 06/16/2023

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: 06/09/2025
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36709
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/16/2023
• Date Device Manufactured: 06/09/2022
• 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: 71 YR
• Patient Sex: Female