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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/14/2025
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
The device had to be revised due to a dislocation of the implant.The device was repositioned on (b)(6) 2025.The repositioning procedure was done without touching the electrode; however, the next ct-scan check revealed that the electrode migrated out of the cochlea, with showing only 3 or 4 channels in the basal part of the cochlea.It was therefore decided to reopen the sutures on the same day, to reinsert the electrode.Once the electrode was located, it was decided to explant the device.After explantation, damage to the electrode was observed.The device showed four channels, and the front part of the electrode had disappeared and could no longer be found.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the revision surgery.According to the information received from the field the recipient underwent a revision surgery due to a migration of the implant housing from its intended position.Diagnostic imaging after the revision surgery showed the electrode partially outside of cochlea likely due to being pulled out.Another revision surgery was performed during which the device was inadvertently damaged and explanted.This is a final report.
Event or Problem Description
The device had to be revised due to a dislocation of the implant.Due to migrated electrodes, it was decided to reopen the sutures on the same day, to reinsert the electrode.Once the electrode was located, it was decided to explant the device.After explantation, damage to the electrode was observed.The device showed four channels, and the front part of the electrode had disappeared and could no longer be found.The user was re-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: 22901846
• Report Number: 9710014-2025-00775
• Device Sequence Number: 8018061
• Product Code: MCM
• UDI-Device Identifier: 09008737395407
• UDI-Public: (01)09008737395407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/02/2025

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 Model Number: MI1250 SYNCHRONY 2 PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: 80 YR
• Patient Sex: Female