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

Model Number MI1260 SONATA 2

Device Problems Impedance Problem (2950); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

Due to a migration, the hospital had to gradually deactivate channels over time which started in (b)(6) 2023.Which led to only three electrodes functioning, resulting in no benefit for the recipient.The recipient has been explanted and re-implanted with a device from another manufacturer.

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.

Manufacturer Narrative

Conclusion: based on the information received from the field, the recipient had a decrease in hearing benefit.Further, according to the device explanation report form three channels were observed out of cochlea and the electrode lead was found extruded.Device investigation revealed that damage to the active electrode which is consistent with minute device mobility led to device failure over time due to fatigue wire breakages, possibly resulting from electrode movement from its original position.Also, fibrotic tissue in the posterior tympanotomy and surrounding the electrode have been observed, which might have contributed to the electrode displacement.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.

Event Description

The user's hearing performance with the device was affected.Reportedly, the user had only 3 functioning channels, as channels have been gradually deactivated over time, starting in december 2023.The user has been explanted and re-implanted with a new device from another manufacturer.

• Brand Name: SONATA
• Type of Device: 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: 18892555
• MDR Text Key: 337527637
• Report Number: 9710014-2024-00231
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737385439
• UDI-Public: (01)09008737385439
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: MI1260 SONATA 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female