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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Output Problem (3005); Device Handling Problem (3265)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
The user had poor hearing performance with the device, with a slow change in hearing with the device over time.The user was re-implanted.The user's hearing performance with the new device is good.
Additional Manufacturer Narrative
Conclusion: device investigation revealed a deformation at the electrode array which is likely the cause for the short circuits measured shortly after implantation surgery.The observed damage might have occurred during the difficult insertion of the active electrode array into to the cochlea, and it is in line with the possible electrode array compression mentioned by the field personnel.Other mechanical damages found during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
The user had poor hearing performance with the device, with a slow change in hearing with the device over time.There was a difficult insertion at the initial implantation of the device and reportedly the electrode array might have been squeezed/compressed according to field personnel.The user was re-implanted.The user's hearing performance with the new device is good.

• 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: 12201308
• Report Number: 9710014-2021-00536
• Device Sequence Number: 5127798
• Product Code: MCM
• UDI-Device Identifier: 09008737366728
• UDI-Public: (01)09008737366728
• 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: 2020
• Device Explanted Year: 2021
• 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): 12/20/2021

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: 10/24/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: 23 YR
• Patient Sex: Male