MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA; Cochlear Implant

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant had to be removed because the of a positive culture at the implant site.
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 implant had to be removed because the of a positive culture at the implant site.
Additional Manufacturer Narrative
Additional information: according to information received from the field, the recipient had surgical wound dehiscence, with pseudomonas being isolated from the fat tissue inside the cavity.The user reportedly has diabetes and poor glucose control.It was also reported that the device was working properly and that the patient was satisfied.A review of the device sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.The device has been explanted but has not been received 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()577885626
• MDR Report Key: 25689004
• Report Number: 9710014-2026-00616
• Device Sequence Number: 9731579
• Product Code: MCM
• UDI-Device Identifier: 09008737385385
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: Mi1260 SONATA 2
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 07/09/2024
• 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: 45 YR
• Patient Sex: Male