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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
During the initial implantation pre-operative in the box measurements could not be performed.Testing failed, as no connection between the test coil and the implant in the sealed packaging could be established.A back-up device was successfully implanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.However to determine an exact root cause device investigation would be necessary.A back-up device was implanted.The concerned device has not been received for investigation yet.
Event or Problem Description
During the initial implantation pre-operative in the box measurements could not be performed.Testing failed, as no connection between the test coil and the implant in the sealed packaging could be established.A back-up device was successfully implanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.According to the information received from the field the device was not working during preoperative testing.The reported issue could not be confirmed during device investigation.A cause for the failed testing remains unknown.A back-up device was implanted.This is a final report.
Event or Problem Description
During the initial implantation pre-operative in the box measurements could not be performed.Testing failed, as no connection between the test coil and the implant in the sealed packaging could be established.A back-up device was successfully implanted.

• 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: 23423548
• Report Number: 9710014-2025-01013
• Device Sequence Number: 18591609
• Product Code: MCM
• UDI-Device Identifier: 09008737093952
• UDI-Public: (01)09008737093952
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2026

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 Model Number: MI1200 SYNCHRONY
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 10/27/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/21/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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 Sex: Unknown