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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Lack of Effect (4065)
Health Effect - Clinical Codes	Head Injury (1879); Failure of Implant (1924)
Date of Event	08/19/2024
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 user sustained a head trauma.The user reported no significant change to hearing impression at the time of testing, which was shortly after the trauma.It was advised to monitor for changes to hearing impression and electrode status.Re-implantation date has been set on (b)(6) 2024.
Event or Problem Description
The user sustained a head trauma.The user initially reported no significant change to hearing impression at the time of testing, which was shortly after the trauma.It was advised to monitor for changes to hearing impression and electrode status.As per further clarification received from the field, there was a decrease in hearing performance over time.Re-implantation has been done on (b)(6) 2024.
Additional Manufacturer Narrative
Conclusion: based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem.The recipient's perception was unsatisfactory; however, no technical problem could be detected.Based on the recipient report the reason for the reduced benefit for the recipient seems to be non-device related.Reportedly one channels was left extra-cochlear at implantation.Further one channel showed high impedance whilst implanted, however the high channel could not be confirmed during device investigation.This is a final report.

• 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: 20046650
• Report Number: 9710014-2024-00762
• Device Sequence Number: 20832640
• Product Code: MCM
• UDI-Device Identifier: 09008737395476
• UDI-Public: (01)09008737395476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/06/2025

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: 12/03/2023
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• 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: 55 YR
• Patient Sex: Male