MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; Cochlear Implant

Model Number	Mi1200 SYNCHRONY
Medical Device Problem Codes	Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user reported persistent pain over an extended period, as well as intermittent disconnections between the implant and the external device.
Event or Problem Description
The user reported persistent pain over an extended period, as well as intermittent disconnections between the implant and the external device.The user has been reimplanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received, the recipient suffered from persistent pain.Pain is a known undesired side effects of otologic surgery.Further, in situ measurements whilst implanted showed one channel in status hi due to undetermined reasons.The recipient has been reimplanted and is doing well with the new device.This is a final report.Note: imdrf investigation findings code is c1902.

• 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()577885626
• MDR Report Key: 23093667
• Report Number: 9710014-2025-00869
• Device Sequence Number: 13213726
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• 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: 2019
• Device Explanted Year: 2026
• 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): 09/02/2026

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 Expiration Date: 01/28/2022
• Device Model Number: Mi1200 SYNCHRONY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2026
• 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: 09/07/2025
• Supplement Date Received by Manufacturer: 09/07/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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: 20 YR
• Patient Sex: Female