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	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The user has experienced recurring episodes of swelling in the area of the internal component.The first episode occurred around 2 years ago, in 2022.Explantation surgery is scheduled for (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: device explanted 6 years after implantation due to recurrent episodes of swelling that did not resolve with medical treatment.With the available information, it appears to be likely related to an infection that was not eradicated with the provided treatment.A review of device sterilization records shows that the device has been subject to a valid sterilization process.Given this, and the timing of the symptoms, no information points towards the implant being the source of the possible infection, but its contribution to the severity of the infection cannot be ruled out.No in situ measurements have been received for investigation.However no allegation was made against the device.The device was explanted but has not been received for investigation yet.
Event or Problem Description
The user has experienced recurring episodes of swelling in the area of the internal component.The first episode occurred around 2 years ago, in 2022.The user has been explanted.
Event or Problem Description
The user has experienced recurring episodes of swelling in the area of the internal component.The first episode occurred around 2 years ago, in 2022.The recipient has been explanted.
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.The device was explanted 6 years after implantation due to recurrent episodes of swelling that did not resolve with medical treatment.With the available information, it appears to be likely related to an infection that was not eradicated with the provided treatment.A review of device sterilization records shows that the device has been subject to a valid sterilization process.Given this, and the timing of the symptoms, no information points towards the implant being the source of the possible infection, but its contribution to the severity of the infection cannot be ruled out.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: 20703625
• Report Number: 9710014-2024-01025
• Device Sequence Number: 8211362
• Product Code: MCM
• UDI-Device Identifier: 09008737049157
• UDI-Public: (01)09008737049157
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 03/20/2025

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: 09/08/2016
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 11/06/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/04/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2014
• 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: 10 YR
• Patient Sex: Female