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	08/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The recipient was accompanied with parent on (b)(6) 2024 reporting swelling on the implant site and mentioning a history of fall, however, the event information was not detailed.After the swelling was settled, the child was mentioning that the auditory perception was affected.Further technical checks are considered.
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: based on the received information, a damage to the active electrode due to excessive mechanical stress caused by the reported trauma appears very likely.Furthermore, a complete insertion was not achieved at implantation surgery with four channels remaining extra-cochlear.In addition, the recipient suffered from a temporary swelling at the implant site due to the reported trauma.However, to determine an exact root cause device investigation would be necessary.Further checks are planned but no date has been scheduled yet.
Event or Problem Description
The recipient was accompanied with parent on (b)(6) 24 reporting swelling on the implant site and mentioning a history of fall, however, the event information was not detailed.After the swelling was settled, the child was mentioning that the auditory perception was affected.Further technical checks are considered.

• 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: 21099222
• Report Number: 9710014-2025-00009
• Device Sequence Number: 15610719
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/22/2025

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 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/22/2025
• 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: 5 YR
• Patient Sex: Male