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	Failure of Implant (1924)
Date of Event	03/08/2024
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
According to the distributor, no trauma was reported.In situ testing showed affected channels.Furthermore, the recipient has a cochlear malformation; cochlear hypoplasia with a single turn of the cochlea and the entrance of the round window is ossified, and auditory nerve hypoplasia.According to recipients family, she showed reaction to sound and localization.Re-implantation is scheduled for (b)(6) 2024.
Event or Problem Description
According to the distributor, no trauma was reported.In situ testing showed affected channels.Furthermore, the recipient has a cochlear malformation; cochlear hypoplasia with a single turn of the cochlea and the entrance of the round window is ossified, and auditory nerve hypoplasia.According to recipients' family, she showed reaction to sound and localization.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.In addition, a complete insertion was not achieved at implantation surgery with four channels remaining extra-cochlear due to ossification.Other damages found during device investigation are most likely related to the explantation surgery.The problems given in the recipient report appear to match the damage found.This is a final 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 ; 57788
• MDR Report Key: 19318508
• Report Number: 9710014-2024-00432
• Device Sequence Number: 12342328
• Product Code: MCM
• UDI-Device Identifier: 09008737385408
• UDI-Public: (01)09008737385408
• 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: 2023
• Serviced by Third Party (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): 08/12/2024

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 Expiration Date: 11/30/2025
• 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: 05/04/2024
• Supplement Date Received by Manufacturer: 05/04/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: 22 MO
• Patient Sex: Female