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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, the user was admitted to the emergency room as he blew his nose and forced air up under his flap.The user is 5 days post ci surgery.He reported pain immediately after doing this.The user was placed on pain medication and antibiotics.At a follow up with the surgeon on (b)(6) 2025, it was reported that the air bubble seems to have resolved.The user's impedances reportedly normalized a few visits ago.
Additional Manufacturer Narrative
Conclusion: based on the received information from the field, it seems that the reported issue might be related to a transient air bubble over the reference electrode, cause by nose-blowing.In addition, air was present in the cochlea, which over time subsided.Furthermore, the reported performance issues are likely related to the recipient's implant using behavior and the late implantation after around 35 years of deafness at the concerned side.The recipient has single-sided deafness.As of now, the device remains implanted and in use.This is a final report.
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
On (b)(6) 2025, the user was admitted to the emergency room as he blew his nose and forced air up under his flap.The user is 5 days post ci surgery.He reported pain immediately after doing this.At initial activation on (b)(6) 2025, the user reported various_ feeling_ sensations, but left the session being able to hear sound with the device.The user was seen again on (b)(6) 2025 for follow up.Initially he stated that it felt like a "9 volt battery" in his head which is why he had not been wearing the device.Re-mapping as done, channels were deactivated and he reported improvement.He will be seen again for follow-up.

• 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: 21717395
• Report Number: 9710014-2025-00293
• Device Sequence Number: 11926348
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 07/07/2025
• Date Device Manufactured: 08/29/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Male