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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2024
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 underwent a revision surgery.According to the audiologist, the user had several fitting appointments because voices and sounds tended to be high-pitch sounds.In addition, basal electrodes started to have lower values in the voltages and there was no hearing perception at stimulation.Before revision surgery the user had only 5 active channels.During revision surgery the active electrode bended several times and got a bad shape for insertion.It was therefore decided to remove the implant and reimplant with a new device.A full insertion was achieved.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient underwent a revision surgery due to migration of the active electrode, which was confirmed by diagnostic imaging.However during revision surgery a device damage was suspected and the concerned device was explanted.Device investigation revealed minor damage to the active electrode array, which is likely related to insertion attempts during revision surgery.This is a final report.
Event or Problem Description
The user_s hearing performance with the device was affected.During the revision surgery on (b)(6) 2024 only 4 channels were found inside the cochlea.The reinsertion of the electrode was difficult due to fibrosis inside the round window.After several insertion attempts the electrode array seemed to get bent and it was therefore decided to reimplant a new device.A full insertion was achieved.

• Brand Name: SYNCHRONY
• 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: 18684279
• Report Number: 9710014-2024-00128
• Device Sequence Number: 15264685
• Product Code: MCM
• UDI-Device Identifier: 09008737395391
• UDI-Public: (01)09008737395391
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 04/25/2024

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: 03/13/2025
• Device Model Number: MI1250 SYNCHRONY 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2022
• 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: 18 YR
• Patient Sex: Male