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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user's hearing performance with the device is affected.The user was sent to the emergency department on (b)(6) 2025 and then followed up with a physician.They did a ct and gave a pressure dressing as well as oral antibiotics.The user continued to experience ongoing pain and swelling, thus he underwent a procedure on (b)(6) 2025 to evacuate infection and blood from under the skin flap and assess implant integrity, which was confirmed as functioning normally, and the clinic decided to preserve the current device with plans for potential use in 3-4 weeks if healing progresses.
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 was sent to the emergency department on (b)(6) 2025 and then followed up with a physician du to swelling and pain.They did a ct and gave a pressure dressing as well as oral antibiotics.The user continued to experience ongoing pain and swelling; thus, he underwent a procedure on (b)(6) 2025 to evacuate infection and blood from under the skin flap and assess implant integrity, which was confirmed as functioning normally, and the clinic decided to preserve the current device with plans for potential use in 3-4 weeks if healing progresses.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient suffered from discomfort at the implant site due to an infection and swelling.A medical treatment to evacuate infection and blood from under the skin flap was performed.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of infection.The device remains implanted and in use.This is a 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 ; 57788
• MDR Report Key: 21353397
• Report Number: 9710014-2025-00123
• Device Sequence Number: 9127064
• Product Code: MCM
• UDI-Device Identifier: 09008737395445
• UDI-Public: (01)09008737395445
• 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: 2022
• 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): 03/13/2025

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: 09/15/2024
• Device Model Number: MI1250 SYNCHRONY 2 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: 02/05/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 09/15/2021
• 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: 11 YR
• Patient Sex: Male