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	Cholesteatoma (4920)
Date of Event	09/16/2025
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
The user was admitted to hospital with a complicated ductal cholesteatoma and soft tissue infection at the internal device site.A subtotal petrosectomy and explantation of the device were performed on (b)(6) 2025.She developed postoperative meningitis and received six weeks of antibiotic treatment, to which she responded well.
Event or Problem Description
The user was admitted to hospital with a complicated ductal cholesteatoma and soft tissue infection at the internal device site.A subtotal petrosectomy and explantation of the device were performed on (b)(6) 2025.She developed postoperative meningitis and received six weeks of antibiotic treatment, to which she responded well.A subtotal petrosectomy and explantation of the device were performed on (b)(6) 2025.After device explantation, the user developed meningitis and received six weeks of antibiotic treatment, to which she responded well.The source of the infection is likely the ongoing reported device unrelated soft tissue infection.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Damages found during device investigation are most likely related to the explantation surgery.This finding was expected, because according to the information received, the device was explanted due to device-unrelated medical reasons i.E.Cholesteatoma and soft tissue infection which spread to the implant area.Furthermore, during device explantation the electrode was found to be exposed in the external auditory canal.The posterior wall dehiscence is reported to be secondary to the radiation of the bone as treatment of medulloblastoma, and the cholesteatoma and the infection could have also contributed to the bone erosion.The cholesteatoma and the posterior canal wall dehiscence appears to have predisposed the patient to the recurrent infections.Furthermore, a review of the device's sterilization records shows that the device has been subject to a valid sterilization process, thus no information available points to the implant being the source of the infection.This is a final report.

• 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: 23580128
• Report Number: 9710014-2025-01077
• Device Sequence Number: 9641689
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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): 01/14/2026

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: 02/01/2022
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: 37 YR
• Patient Sex: Female