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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2022 a soft tissue swelling was treated with antibiotics.The swelling reoccurred, thus in (b)(6) 2022 a needle aspiration was performed.On (b)(6) 2022 the user underwent surgery where the device was removed from the implant site, the implant side was cleaned, and then the device was reimplanted.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery in (b)(6) 2022 due to an infection at the implant site.Reportedly the implant site was cleaned and the device was put back in place.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.The device remained implanted and in use.
Event or Problem Description
In (b)(6) 2022 a soft tissue swelling was treated with antibiotics.The swelling reoccurred, thus in (b)(6) 2022 a needle aspiration was performed.On (b)(6) 2022 the user underwent surgery where the device was removed from the implant site, the implant side was cleaned, and then the device was reimplanted.

• 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: 24276639
• Report Number: 9710014-2026-00123
• Device Sequence Number: 12906556
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 02/11/2024
• Device Model Number: MI1210 SYNCHRONY ST
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 02/11/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male