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	Headache (1880)
Date of Event	09/12/2024
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
On (b)(6) 2024 the user complaint of a headache.The following day the user went to the hospital for examination ((b)(6) 2024).Ct imaging showed that a part of the active electrode migrated into the vestibule.The user was reimplanted.
Additional Manufacturer Narrative
Based on the information received from the field, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea.Reportedly, the recipient reported headaches, which might be caused by extra-cochlear stimulation in the middle ear.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
On (b)(6) 2024 the recipient reported experiencing a headache.The following day the recipient went to the hospital for examination.The recipient has been re-implanted.
Event or Problem Description
On (b)(6) 2024 the recipient reported experiencing a headache.The following day the recipient went to the hospital for examination.The recipient has been re-implanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.Based on the information received from the field, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea.Reportedly, the recipient reported headaches, which might be caused by extra-cochlear stimulation in the middle ear.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: 20253220
• Report Number: 9710014-2024-00850
• Device Sequence Number: 8667731
• Product Code: MCM
• UDI-Device Identifier: 09008737049188
• UDI-Public: (01)09008737049188
• 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: 2021
• 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): 11/06/2024

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: 04/06/2023
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 09/18/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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: 9 YR
• Patient Sex: Female