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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Codes	Circuit Failure (1089); Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
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
Reportedly the position of the implant body changed over time.Recurring swelling and infections over several years are reported.The user was hospitalized several times due to inflammation of the operated ear.He was treated with antibiotics according to the microbiological findings.Granulations were found on the back (posterior) wall of the ear canal (which were previously confirmed histopathologically).Also the operation in (b)(6) 2024 (incisio abscessus retroauricularis l.Son.) was done due to the recurring swelling.A ct scan of the temporal bone was performed as well.A biopsy was taken and the wound was swabbed.The child was discharged on 04-mar-2024 in good general condition.Granulations and smaller pieces of bone are present in the mastoid cavity.Reportedly, the position of the electrode is correct.Finally, the device was explanted as the user's parents did not want the child to have a repositioning surgery.
Event or Problem Description
Reportedly the position of the implant body changed over time.The device was explanted as the user's parents did not want the child to have a repositioning surgery.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to a migration of the implant housing from its intended position.Further the recipient suffered from several episodes of inflammation and swelling.Therefore the recipient underwent a revision surgery in 2024.A review of device sterilization records shows that the device has been subject to a valid sterilization process.Therefore, no information points towards the implant being the source of the inflammation.The explanted device has not been received for investigation yet.

• 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: 21777901
• Report Number: 9710014-2025-00312
• Device Sequence Number: 20991685
• Product Code: MCM
• UDI-Device Identifier: 09008737331825
• UDI-Public: (01)09008737331825
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 02/14/2025
• Device Model Number: MI1210 SYNCHRONY ST
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 02/14/2022
• 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; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male