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

Model Number	SONATA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2024
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
The parent reported that the recipient did not have a good benefit from the device after implantation in 2014, however, this was not earlier reported.As the hearing benefit with the device got even worse this year, the recipient with his parent went to the hospital for further examination in early august 2024.The recipient has been re-implanted with a compressed array.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device did not provide sufficient benefit due to a complete migration of the active electrode out of cochlea.Furthermore, ossification was found, which might has contributed the observed issue.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The parent reported that the recipient did not have a good benefit from the device after implantation in 2014, however, this was not earlier reported.As the hearing benefit with the device got even worse this year, the recipient with his parent went to the hospital for further examination in early (b)(6) 2024.The recipient has been re-implanted with a compressed array.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.Based on the received information from the field, the device did not provide sufficient benefit due to a complete migration of the active electrode out of cochlea.Furthermore, ossification was found, which might has contributed the observed issue.This is a final report.
Event or Problem Description
The parent reported that the recipient did not have a good benefit from the device after implantation in 2014, however, this was not earlier reported.As the hearing benefit with the device got even worse this year, the recipient with his parent went to the hospital for further examination in early (b)(6) 2024.The recipient has been re-implanted with a compressed array.

• 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: 20073558
• Report Number: 9710014-2024-00767
• Device Sequence Number: 6414151
• Product Code: MCM
• UDI-Device Identifier: 09008737049171
• UDI-Public: (01)09008737049171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 10/17/2024

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: 11/01/2015
• Device Model Number: SONATA
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 08/23/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/13/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2013
• 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: 25 YR
• Patient Sex: Male