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	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user hears a buzzing noise when speaking.On june 01, 2022, it was determined that the electrode migrated, and some contacts were outside of the cochlea.Re-insertion surgery took place on july 22, 2022.Shortly after that, the electrode migrated again, and a second re-insertion surgery was done on july 26, 2022.Then the electrode migrated again on (b)(6) 2023.No further surgical intervention was done.A diagnostic image to see the current electrode position will be performed.
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.
Additional Manufacturer Narrative
Conclusion: according to the information received, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of cochlea.The electrode migrated several times and the recipient underwent already two re-insertion surgeries.Reportedly the recipient suffers from a cochlear malformation, which might have contributed to the migration of the electrode.Currently the recipient is still satisfied with the implant and no additional re-insertion surgery is planned.This is a final report.
Event or Problem Description
The user hears a buzzing noise when speaking.On (b)(6), 2022, it was determined that the electrode migrated, and some contacts were outside of the cochlea.Re-insertion surgery took place on (b)(6) 2022.Shortly after that, the electrode migrated again, and a second re-insertion surgery was done on (b)(6), 2022.Then the electrode migrated again on (b)(6), 2023.The clinic does not want to re-insert the electrode once again because of the high risk of another electrode migration due to mondini dysplasia.The user is still satisfied with the implant.No further steps are planned for this ci.

• 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: 18053355
• Report Number: 9710014-2023-00978
• Device Sequence Number: 15194164
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/14/2023

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: 01/10/2023
• Device Model Number: MI1250 SYNCHRONY 2
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/14/2023
• Date Device Manufactured: 01/10/2020
• 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: 48 YR
• Patient Sex: Female