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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.Following implantation surgery, two extracochlear channels were reportedly initially identified.Subsequent imaging revealed three extracochlear electrodes and one electrode located at the round window.Re-insertion is considered.Probably re-insertion and initial implantation on the contralateral side will be done together.No date has been scheduled yet.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the decrease in benefit was most likely caused by a migration of the electrode out of cochlea.The reported pain might be related to extra-cochlear stimulation in the middle ear.Further a complete insertion was not achieved at implantation with likely two extra-cochlear channels.Re-insertion is considered but no date has been scheduled yet.
Event or Problem Description
The user's hearing performance with the device is affected.Following implantation surgery, two extracochlear channels were reportedly initially identified.Subsequent imaging revealed three extracochlear electrodes and one electrode located at the round window.Re-insertion is considered.Probably re-insertion and initial implantation on the contralateral side will be done together.No date has been scheduled yet.

• 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: 22892966
• Report Number: 9710014-2025-00774
• Device Sequence Number: 8851896
• Product Code: MCM
• UDI-Device Identifier: 09008737094034
• UDI-Public: (01)09008737094034
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/29/2025
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/21/2025
• Date Device Manufactured: 11/29/2022
• 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
• Patient Age: 34 YR
• Patient Sex: Female