MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
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 has an infection on the right side and swelling over the implant.The clinic said that the implant is exposed through the skin, and they applied a dressing over the skin.The surgeon is planning to do revision surgery for infection cleaning.It is probable they will remove the implant and cut the electrode for later re-implantation.
Event or Problem Description
The user has an infection on the right side and swelling over the implant.The clinic reported that the implant is exposed through the skin, and they applied a dressing over the skin.The issue started about 3 months ago.The user was treated medically with antibiotics and a head bandage; then it was fine - after two months the swelling started again.Surgery was performed on (b)(6) 2023, but the implant was not explanted.The surgeon cleaned the wound and kept the implant.Reportedly, in situ measurements are indicative of a functional device.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient suffered from an infection at the implant site and extrusion of the device through the skin.A review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of any infection.However, a device contribution to the subsequent development of the extrusion cannot be ruled out.During a revision surgery the wound was cleaned successfully.The device remains implanted and in use.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 17858591
• Report Number: 9710014-2023-00856
• Device Sequence Number: 12307734
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 12/27/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/19/2025
• Device Model Number: MI1250 SYNCHRONY 2
• 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: 09/24/2023
• Supplement Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/27/2023
• Date Device Manufactured: 04/19/2022
• 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: 2 YR
• Patient Sex: Male