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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/28/2024
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
Due to infection the device was explanted on (b)(6) 2024.The user suffered from otitis media which spread to the level of the implant.The infection has been confirmed by cultures: staphylococcus aureus.The issue started 2,5 month ago.At the explantation surgery the housing was in place and hearing was not affected.Re-implantation is considered on a later time point.
Event or Problem Description
Due to infection the device was explanted on (b)(6) 2024.The user suffered from otitis media which spread to the level of the implant.The infection has been confirmed by cultures: staphylococcus aureus.The issue started 2,5 months prior.At the explantation surgery the housing was in place and hearing was not affected.Re-implantation is considered at a later time point.
Additional Manufacturer Narrative
Conclusion: device investigation of the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.Damage found during investigation is most likely related to the removal surgery.This finding was expected, because according to the patient report the device was explanted for medical reasons, namely otitis media which spread to the implant site.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 infection.However, the presence of the device might have contributed to its subsequent development.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: 19069150
• Report Number: 9710014-2024-00327
• Device Sequence Number: 6901208
• Product Code: MCM
• UDI-Device Identifier: 09008737366773
• UDI-Public: (01)09008737366773
• 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: 2020
• Device Explanted Year: 2024
• 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): 05/21/2024

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: 01/21/2023
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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: 41 YR
• Patient Sex: Male