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

Model Number	SONATA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Meningitis (2389)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
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
Reportedly, the recipient had recurrent meningitis since 2020, for about 7 or 8 times, and the clinic suggested to remove the implant first for further treatment of meningitis.After the initial implantation in 2019, the recipient obtained hearing benefits from the device.Cerebrospinal fluid metagenomic testing for pathogens: streptococcus pneumoniae; purulent meningitis is clinically diagnosed.The recipient has been explanted.Re-implantation is considered at a later date.
Event or Problem Description
Reportedly, the recipient had recurrent meningitis since 2020, for about 7 or 8 times, and the clinic suggested to remove the implant first for further treatment of meningitis.After the initial implantation in 2019, the recipient obtained hearing benefits from the device.Cerebrospinal fluid metagenomic testing for pathogens: streptococcus pneumoniae; purulent meningitis is clinically diagnosed.The recipient has been explanted.Re-implantation is considered at a later date.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to information received, the device was explanted due to recurrent of meningitis in the setting of a cochlear malformation and an apparent csf leak, which required surgical repair.Vaccination status is unknown.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, therefore the device is unlikely the source of the infection.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: 22517322
• Report Number: 9710014-2025-00640
• Device Sequence Number: 9231846
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 09/18/2025

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: 03/25/2022
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2019
• 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: 6 YR
• Patient Sex: Female