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

Model Number	SONATA
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Undesired Nerve Stimulation (1980)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient was implanted as single sided deafness (ssd) since a couple of years due to ossifying labyrinthitis.Due to severe ossification, only 3 channels were functional.Reportedly, some channels were extra-cochlear and others cause severe facial nerve stimulation.The recipient had a revision surgery on (b)(6) 2021 due to the extra-cochlear channels, however, without any improvement.The recipient visited another clinic for explantation.
Additional Manufacturer Narrative
The device has been explanted and 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
Hearing performance with the device was affected.Due to severe ossification, only 3 channels were functional.Reportedly, some channels were extra-cochlear, and others caused severe facial nerve stimulation.Therefore, she started to use the audio processor (ap) less and less because of little benefit.The device was explanted on (b)(6) 2024.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the lack of benefit was likely caused by the reported ossification in the cochlea.Reportedly the electrode migrated post-operatively out of cochlea with three channels remaining in the cochlea.The recipient experienced also facial nerve stimulation likely caused by extra-cochlear stimulation due to the migration.A re-insertion surgery was performed leaving most likely one channel extra-cochlear.However, the benefit with the device did not improve and the device was explanted.This is a final report.

• 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: 19717482
• Report Number: 9710014-2024-00616
• Device Sequence Number: 8190898
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 08/14/2024

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: 05/07/2023
• Device Model Number: SONATA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• 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: 70 YR
• Patient Sex: Female