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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Undesired Nerve Stimulation (1980)
Date of Event	02/15/2021
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 showed symptoms of facial nerve stimulation in (b)(6) 2021 while perceiving high pitched sound with the device.Ct imaging has shown that the electrode array of the device had migrated out of the cochlea.
Event or Problem Description
The user showed symptoms of facial nerve stimulation in (b)(6) 2021 while perceiving high pitched sound with the device.Reportedly, the users performance with the device has never been adequate.At an appointment on the 4th march reportedly the user had okay hearing performance.The user was re-mapped.
Additional Manufacturer Narrative
Additional information: according to the recipient report the active electrode migrated partially out of the cochlea, most likely causing the reported facial nerve stimulation.These channels have been disabled.Reportedly the hearing performance is ok now.The device remains implanted and in use.

• 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: 11419863
• Report Number: 9710014-2021-00135
• Device Sequence Number: 11457019
• Product Code: MCM
• UDI-Device Identifier: 09008737094010
• UDI-Public: (01)09008737094010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 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: 12/05/2020
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/05/2021
• 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: 54 YR