MAUDE Adverse Event Report: MED-EL Elektromedizinische Geraete GmbH SYNCHRONY; Cochlear Implant

Model Number	Mi1250 SYNCHRONY 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reports just sounds like beeping and noise with the ci.Testing in the booth revealed poor pure tone thresholds and no speech understanding.User has significant facial twitching on many channels.There is lip twitching at levels that the user describes as soft.Deactivating them made no difference with the sound.Re-implantation done on (b)(6) 2026.
Additional Manufacturer Narrative
Conclusion: according to the information received, the device was explanted due to the recipient not having good benefit from the implant system.A tip fold-over was observed, which might be related to the difficult insertion process at the implantation surgery, due to the recipient's difficult anatomical condition.Furthermore, a facial nerve stimulation was noticed.In addition during device investigation, the active electrode showed wire breakages likely caused by minute device mobility.Other damages found during investigation are most likely related due to removal surgery.This is a combined initial and 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 ; +43-(577)88
• MDR Report Key: 50052389
• Report Number: 9710014-2026-00675
• Device Sequence Number: 13421855
• Product Code: MCM
• UDI-Device Identifier: 09008737415440
• UDI-Public: (01)09008737415440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: Mi1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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 Age: 42 YR
• Patient Sex: Male