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	Mastoiditis (4835)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and 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 been explanted due to an infection in the mastoid bowl.The surgeon opted to remove the infection and the implant, and not to reimplant the user until the infection was taken care of.
Event or Problem Description
The user has been explanted due to an infection in the mastoid bowl.The surgeon opted to remove the infection and the implant to reduce possibility of further infection, and not to reimplant the user until the infection was taken care of.The surgeon reported infection was confirmed by cultures, when meeting with the surgeon he was unsure what the result was.The infection began a few weeks prior to the explantation and the patient underwent antibiotics to try and treat the infection.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to an infection in the mastoid.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 the infection.However, the presence of the device might have contributed to its subsequent development.In addition, the two most basal channels were disabled due to insufficient benefit.The explanted device has not been received for investigation yet.
Event or Problem Description
The user has been explanted due to an infection in the mastoid bowl.The surgeon opted to remove the infection and the implant to reduce possibility of further infection, and not to reimplant the user until the infection was taken care of.The surgeon reported infection was confirmed by cultures, when meeting with the surgeon he was unsure what the result was.The infection began a few weeks prior to the explantation and the patient underwent antibiotics to try and treat the infection.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to an infection in the mastoid.A review of the devices 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 the infection.However, the presence of the device might have contributed to its subsequent development.In addition, the two most basal channels were disabled due to insufficient benefit.A part of the electrode has been received for investigation and shows no abnormalities.The remainder device part has not been received for investigation.

• 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: 21382971
• Report Number: 9710014-2025-00138
• Device Sequence Number: 8525902
• 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: 2021
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/08/2025

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: 04/06/2024
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/12/2024
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/12/2025; 05/09/2025
• Date Device Manufactured: 04/06/2021
• 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: 84 YR
• Patient Sex: Male