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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user attended a programming visit session on (b)(6) 2023.She reported that since the previous session he had been was unable to tolerate stimulation, due to discomfort and metallic taste sensations.However, the device on this side has not been worn for years.While running insitu testing, a strong metallic taste and buzzing sensation to the right side of tongue was reported.Sensations were also reported though when there was no stimulation.Audiologist requested another ct scan for concerns of further migration of the electrode array.
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
Additional information: based on the received information the reported problems are likely due to a migration of the active electrode out of cochlea.Reportedly also an incomplete insertion at the implantation surgery was achieved.Currently no surgical intervention is considered.
Event or Problem Description
The user attended a programming visit session on (b)(6) 2023.She reported that since the previous session she had been unable to tolerate stimulation, due to discomfort and metallic taste sensations.However, the device on this side has not been worn for years.While running in situ testing, a strong metallic taste and _buzzing sensation_ to the right side of tongue was reported.Sensations were also reported though when there was no stimulation.Last diagnostic imaging in (b)(6) 2022 reportedly already showed migration of device.Another ct scan has been requetsed for concerns of further migration of the electrode array.Additional visit scheduled for (b)(6).The user is currently advised to not use device given her adverse reports with current maps (has active electrodes in current maps that are extracochlear) she is following up in (b)(6).There is no plan of revising an ossified cochlea.No further action is planned aside from programming suggestions.

• 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: 17141835
• Report Number: 9710014-2023-00509
• Device Sequence Number: 13935988
• Product Code: MCM
• UDI-Device Identifier: 09008737062699
• UDI-Public: (01)09008737062699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 03/31/2015
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/29/2023
• Date Device Manufactured: 04/16/2013
• 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
• Patient Age: 76 YR
• Patient Sex: Female