MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; COCHLEAR IMPLANT

Model Number	SONATA
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient had meningitis and had a lot of ossification at the time of implantation.A compressed electrode was placed, however, a good insertion could not be achieved leaving 2 channels out of cochlea, although the doctor tried different approaches.The recipient was not using the device much due to facial stimulation.An appointment with the doctor has been scheduled for (b)(6) 2024 to evaluate further proceedings.
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: according to the information received, the device was not providing benefit to the recipient because the active electrode was not completely inserted inside the cochlea, as confirmed by diagnostic images.Consequently, the recipient experienced facial nerve stimulation likely caused by extra-cochlear stimulation following the misplacement.No further steps are planned at the moment.
Event or Problem Description
The recipient had pneumococcal meningitis prior to being implanted and had a lot of ossification at the time of implantation.A compressed electrode was placed, however, a good insertion could not be achieved leaving 2 channels out of cochlea, even though the doctor tried different approaches.The recipient was not using the device much due to facial stimulation.

• Brand Name: SONATA
• 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: 19925810
• Report Number: 9710014-2024-00704
• Device Sequence Number: 8234949
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 11/20/2024

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: 01/01/2015
• Device Model Number: SONATA
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 02/01/2013
• 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: 14 YR
• Patient Sex: Male