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

Model Number	Mi1260 SONATA 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been implanted 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
Implantation was performed on (b)(6) 2026.The standard procedure was followed, with in-situ testing of the device carried out before implantation.The device was found to be within normal parameters.The active electrode was inserted atraumatically.However, when the intraoperative functional test (ift) was performed, high impedances ranging from 12 to 17 k_ were detected.The device was removed and reinserted, but the results were the same.The backup device was implanted during the same surgical procedure.
Event or Problem Description
Implantation was performed in (b)(6)2026.The standard procedure was followed, with in-situ testing of the device carried out before implantation.The device was found to be within normal parameters.The active electrode was inserted atraumatically.However, when the intraoperative functional test (ift) was performed, high impedances ranging from 12 to 17 k_ were detected.The device was removed and reinserted, but the results were the same.The backup device was implanted during the same surgical procedure.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem.Based on the received information from the field, intra-operatively no nrt response was obtained.The issue seems likely to be related to a insufficient contact of the reference electrode to connective tissue.The ift measurement shows the gpi to be high.A back-up device as implanted instead within the same procedure.This is a final report.Note: investigation finding code c1902 is chosen code not yet accepted by fda system.

• 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: 25688998
• Report Number: 9710014-2026-00617
• Device Sequence Number: 9731576
• Product Code: MCM
• UDI-Device Identifier: 09008737385453
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (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): 09/16/2026

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: Health Professional
• Device Model Number: Mi1260 SONATA 2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• 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: 06/16/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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: 8 YR
• Patient Sex: Female