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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2025
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
The user was implanted in (b)(6) 2024 and underwent a second stage surgery in (b)(6) 2024 for blind sac closure.It is suspected that the electrode might have been disturbed during revision.The user reported poorer hearing following revision and no benefit at follow up in (b)(6) 2024, therefore reimplantation was done (b)(6) 2025.The user will be seen again in the clinic in (b)(6) 2025 for activation of the new device.
Event or Problem Description
The user was implanted in (b)(6) 2024 and underwent a second stage surgery in (b)(6) 2024 for blind sac closure.It is suspected that the electrode might have been disturbed during revision.The user reported poorer hearing following revision and no benefit at follow up in (b)(6) 2024, therefore reimplantation was done (b)(6) 2025.The user will be seen again in the clinic in (b)(6) 2025 for activation of the new device.
Additional Manufacturer Narrative
Conclusion: device investigation revealed mechanical damages to the active electrode lead.This damage most likely happened inadvertently during a device unrelated surgery namely blind sac closure.Other mechanical damages found are related to the explantation surgery.The investigation findings go in line with the reported issue.This s 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: 21272044
• Report Number: 9710014-2025-00086
• Device Sequence Number: 19785802
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 03/10/2025

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: 10/18/2024
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: 70 YR
• Patient Sex: Male