MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; Cochlear Implant

Model Number	Mi1210 SYNCHRONY ST
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/29/2026
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
Since the implantation surgery, the user had recurring infection.The device was explanted.
Event or Problem Description
Since the implantation surgery, the user had recurring infection.The device was explanted.
Event or Problem Description
Since the implantation surgery, the user had recurring infection.The device was explanted.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field the device was explanted due to re-occurring infection and extrusion of the device through the skin.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 reported issue.However, the presence of the device might have contributed to its subsequent development.In addition in situ measurements show several channels with fluctuating hi status due to undetermined reasons.This is a final report.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to re-occurring infection and extrusion of the device through the skin.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 reported issue.However, the presence of the device might have contributed to its subsequent development.A revision surgery was performed in (b)(6)2026 however the issue reoccurred and the device was explanted.In addition, in situ measurements show several channels with fluctuating hi status due to undetermined reasons.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 ; +43()577885626
• MDR Report Key: 25108680
• Report Number: 9710014-2026-00416
• Device Sequence Number: 9322259
• Product Code: MCM
• UDI-Device Identifier: 09008737331832
• UDI-Public: (01)09008737331832
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 09/17/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/23/2020
• Device Model Number: Mi1210 SYNCHRONY ST
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 04/29/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/18/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 9 YR
• Patient Sex: Male