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
Event or Problem Description
Information was received on a cochlear implant surgical survey that there was 1 high channel at implantation.The user did not have good performance at activation due to the partial insertion.Reportedly, a full insertion of the flex24 array was achieved.However, according to clinical support's analysis of the imaging channels 7-12 are extra-cochlear based on imaging performed on the (b)(6) 2022.Revision surgery for this side is under discussion.
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 received on a cochlear implant surgical survey that there was 1 high channel at implantation which was performed on the (b)(6) 2022.Reportedly a full insertion was achieved at implantation and there were no difficulties report.However, imaging from the (b)(6) 2022 would show that channels 7-12 are extra-cochlear.The user did not have good performance at activation due to the partial insertion.Revision surgery for this side is under discussion, however, they will wait 6 months to evaluate the user_s performance.
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 as confirmed by diagnostic imaging.Further the most apical channel shows hi status due to undetermined reasons.Revision surgery is considered but no date has been scheduled yet.

• 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: 16085450
• Report Number: 9710014-2023-00001
• Device Sequence Number: 13961668
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• 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): 03/08/2023

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: 05/22/2025
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39571
• 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: 12/29/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• 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: 12 YR
• Patient Sex: Male