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

Model Number	MI1260 SONATA 2
Medical Device Problem Codes	Impedance Problem (2950); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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
At the surgery, on (b)(6) 2025, the surgeon had to manipulate the tip of the electrode lead a litte (it was a bit tilted to one side, causing a problem to make insertion).The surgeon has lots of experience with med-el and did not use much force or pending to electrode, but had to manipulate it several times to get it straighter.The user has been explanted.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field in situ measurements show the four most apical channels with hi status since implantation surgery.Device investigation revealed damage to the active electrode array, which was most likely caused during manipulation of the electrode during implantation surgery.This is a final report.
Event or Problem Description
At the surgery on (b)(6) 2025 the surgeon had to manipulate the tip of the electrode lead a litte (it was a bit tilted to one side, causing a problem to make insertion).The surgeon has lots of experience with med-el and did not use much force or pending to electrode, but had to manipulate it several times to get it more straight.The user has been explanted.

• 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: 23816469
• Report Number: 9710014-2025-01172
• Device Sequence Number: 9295201
• Product Code: MCM
• UDI-Device Identifier: 09008737385453
• UDI-Public: (01)09008737385453
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male