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	Skin Infection (4544)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user's mother reported swelling and fluid/pus discharge at the implant site.Initially, signs were consistent with infection, with no evidence of extrusion.In (b)(6)2026, it was reported that the internal component had become visible.According to the images sent, the implant has extruded through the skin.As per new information received, the patient's condition began in mid-2025, with the appearance of a small pustule in the right mastoid region and occasional right-sided otorrhea.The treating ent performed drainage and prescribed antibiotics.In (b)(6) 2025, in situ measurements were within normal limits.During the same month, recurrent signs of right-sided mastoiditis occurred.A ct scan shows opacification of the right mastoid with isodense material and adequate positioning of the cochlear implant.As an incidental finding, a cyst was observed in the right temporal region, with displacement of the structures toward the midline.A culture of the drainage showed growth of s.Aureus and s.Pneumoniae, both susceptible to levofloxacin and ceftriaxone.The patient was hospitalized at the end of (b)(6) 2025 and underwent surgery on (b)(6) 2025, for drainage and cleaning of the mastoid cavity.She was treated with cefepime and metronidazole.During follow-up with the ent department in (b)(6) 2026, the pathology report showed chronic granulomatous inflammation of foreign-body type, with mild acute inflammation associated with granulation tissue in the mastoid region.At that time, no further otorrhea was reported, and the surgical wound was described as clean and well healed.On (b)(6)2026, the patient's parents report that the user had developed inflammation in the implant area, with intact skin and no exposure of the cochlear implant at that time, as well as purulent drainage.By (b)(6) 2026, exposure of the internal component had already begun to develop.On (b)(6) 2026 examination showed partial exposure of the internal component, inflammatory tissue, and a small amount of purulent secretion.The wound was covered with clean gauze, and the parents reported performing daily cleaning and wound care.
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.

• 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: 50685535
• Report Number: 9710014-2026-00842
• Device Sequence Number: 21441474
• Product Code: MCM
• UDI-Device Identifier: 09008737385453
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Expiration Date: 04/19/2026
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 04/19/2023
• 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: 8 YR
• Patient Sex: Female