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

Model Number	MI1210 SYNCHRONY ST
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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
The user is experiencing facial stimulation but no auditory stimulation on channels 11 and 12.The user also feels a current in the tongue on these channels.
Additional Manufacturer Narrative
Additional information: according to the recipient report, diagnostic imaging confirmed a partial active electrode migration out of the cochlea, most likely causing the observed non-auditory stimulation.In addition, in situ measurements show the three most apical channels with high impedance due to currently undetermined reasons.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user is experiencing facial stimulation but no auditory stimulation on channels 11 and 12.The user also feels a current in the tongue on these channels.Re-implantation is recommended but has not been decided upon yet.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11176431
• Report Number: 9710014-2021-00023
• Device Sequence Number: 2994607
• Product Code: MCM
• UDI-Device Identifier: 09008737331863
• UDI-Public: (01)09008737331863
• 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
• 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): 04/20/2021

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: 01/25/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR