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

Model Number	MI1260 SONATA 2
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
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
During surgery for a bilateral cochlear implantation case, the surgeon opened an intact, sealed med-el cochlear implant intended for insertion in the left ear.Prior to handing over the implant to the surgeon the audiology team performed in-package telemetry as per standard protocol.At that time, the in package telemetry results were completely normal, and no abnormality was detected.However, upon opening the implant box in the ot and while preparing the device for surgical insertion, it was observed that the internal magnet was loose and became automatically expelled from its housing without any manual force or manipulation.The implant had not yet been handled for placement.Immediately after identifying the issue, the implant was not used.The device was carefully kept in its original box in the same condition as observed.To proceed with the surgery and ensure user safety, the alternate implant that was originally planned for the contralateral ear was used instead.No attempt was made to reinsert or manipulate the expelled magnet.

• 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: 24200676
• Report Number: 9710014-2026-00075
• Device Sequence Number: 20188550
• Product Code: MCM
• UDI-Device Identifier: 09008737385385
• UDI-Public: (01)09008737385385
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: MI1260 SONATA 2
• 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: 01/18/2026
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 06/02/2025
• 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 Sex: Unknown