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

Model Number	MI1260 SONATA 2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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 recipient reported that he does not hear anything and has no benefit from the device.Currently, the recipient does not respond to any charge increase and reported discomfort under charge increase.Eabr testing is considered.The surgeon has scheduled an appointment for (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device is not providing the expected auditory benefit to the recipient.Recent diagnostic imaging suggests an underlying anatomical anomaly, characterized by an unusually large cochlear duct length (cdl) and an apical region that appears incompletely segmented and cystic.Furthermore, partial migration of the electrode array was observed, with three electrodes now located outside the cochlea.The electrode array also fails to fully cover the basal turn, indicating a shallow insertion.In situ testing showed the device to be working within specifications.Hence, the anatomical factors likely contribute to both the electrode migration and the compromised auditory outcomes.
Event or Problem Description
The recipient reported that he does not hear anything and has no benefit from the device.Currently, the recipient does not respond to any charge increase and reported discomfort under charge increase.Eabr testing is considered.The surgeon has scheduled an appointment for (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the device is not providing the expected auditory benefit to the recipient.Recent diagnostic imaging suggests an underlying anatomical anomaly, characterized by an unusually large cochlear duct length (cdl) and an apical region that appears incompletely segmented and cystic.Furthermore, partial migration of the electrode array was observed, with three electrodes now located outside the cochlea.The electrode array also fails to fully cover the basal turn, indicating a shallow insertion.In situ testing showed the device to working within specifications.Hence, the anatomical factors likely contribute to both the electrode migration and the compromised auditory outcomes.Further, the recipient experienced pain at the implant site, which is most likely related to the mentioned migration of the implant housing from its intended position.
Event or Problem Description
The recipient reported that he does not hear anything and has no benefit from the device.He does not respond to any charge increase and reported discomfort under charge increase.Triphasic pulse have been used where the recipient referred to hear softly and to have a slightly hearing perception.Further, the user reports a lot of pain in the area of the coil.The implant has descended.

• 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: 19947354
• Report Number: 9710014-2024-00714
• Device Sequence Number: 7126659
• Product Code: MCM
• UDI-Device Identifier: 09008737385446
• UDI-Public: (01)09008737385446
• 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,Followup
• Report Date (Section B): 01/08/2025

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: 11/28/2025
• Device Model Number: MI1260 SONATA 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 08/08/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/09/2024; 01/08/2025
• Date Device Manufactured: 11/28/2022
• 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
• Patient Age: 47 YR
• Patient Sex: Male