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

Model Number	SONATA
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
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
The parent reported that the recipient had a head trauma near the implant in early june 2024 with result in the loss of hearing with device.Swelling and redness were seen.The recipient has been re-implanted.
Event or Problem Description
The parent reported that the recipient had a head trauma near the implant in (b)(6) 2024 with result in the loss of hearing with device.Swelling and redness was seen.The recipient has been re-implanted.
Additional Manufacturer Narrative
According to the information received from the field damage to the reference electrode caused by the reported mechanical impact seems likely.In addition, two channels show high impedance likely related to a damage of the active electrode caused by the reported trauma.However to determine an exact root cause, device investigation of the explanted device would be necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The parent reported that the recipient had a head trauma near the implant in early (b)(6) 2024 with result in the loss of hearing with device.Swelling and redness was seen.The recipient has been re-implanted.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by the reported external impact, was determined to be the root cause of the device failure.Furthermore, damage to the active electrode caused by excessive mechanical stress was found causing the reported channels with high impedance.Other damages found during device investigation are most likely related to the explantation surgery.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: 20073813
• Report Number: 9710014-2024-00768
• Device Sequence Number: 20436552
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• 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: 2022
• 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): 12/06/2024

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: 07/20/2023
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 08/27/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/10/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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: 4 YR
• Patient Sex: Male