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

Model Number	SONATA
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Breakdown (2681)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The parents brought the child to the hospital due to recurrent infections and lack of response to sounds for 1 year.During otoscopic examination, the electrode lead was visible through the ear canal.Bland sac closure was performed during the initial surgery.Clinic is planning to do explantation and reimplantation with a new device in the opposite side.
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 parents brought the child to the hospital due to recurrent infections and lack of response to sounds for 1 year.During otoscopic examination, the electrode lead was visible through the ear canal.
Additional Manufacturer Narrative
Additional information: according to information received, the electrode lead was exposed in the middle ear after blind sac dehiscence due to the repeated device unrelated infections.The reported lack of hearing may have been multifactorial, including impedance fluctuations due to changes in the perilyphatic fluid due to the reported infections.In situ measurements show two channels involved in a short circuit due to undetermined reasons.Apart from this, the device works within specifications.A device explantation is planned but has not been conducted yet.

• 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 ; +43- 57788-5626
• MDR Report Key: 24441489
• Report Number: 9710014-2026-00190
• Device Sequence Number: 10220655
• Product Code: MCM
• 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: 2016
• 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): 06/17/2026

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: 03/16/2019
• Device Model Number: SONATA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/17/2026
• Date Device Manufactured: 03/16/2016
• 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: 11 YR
• Patient Sex: Female