MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reportedly has an infection and an abscess near the site of the implant.The device will be explanted on (b)(6) 2023.
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
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 recipient report the device was explanted due to an infection and extrusion of the device through the skin.A 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 any infection.However, a device contribution to the subsequent development of the extrusion cannot be ruled out.This is a final report.
Event or Problem Description
The user reportedly has an infection and an abscess near the site of the implant.The infection has reportedly spread to the level of the implant.In (b)(6) 2023, granulation appeared and the user's parents sought medical assistance every 2-4 weeks.On (b)(6) an abscess appeared and the clinic prescribed antibiotics to avoid a second surgery.Between (b)(6) and (b)(6), the abscess broke and the clinic and the parents discussed removing the device.The device was explanted on (b)(6) 2023.
Event or Problem Description
The user reportedly has an infection and an abscess near the site of the implant.The infection has reportedly spread to the level of the implant.In (b)(6) 2023, granulation appeared and the user's parents sought medical assistance every 2-4 weeks.On (b)(6), an abscess appeared and the clinic prescribed antibiotics to avoid a second surgery.Between (b)(6), the abscess broke and the clinic and the parents discussed removing the device.The device was explanted on (b)(6) 2023.
Additional Manufacturer Narrative
Correction: date of awareness changed from 04.Aug.2023 to 03.Aug.2023.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• 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: 17481034
• Report Number: 9710014-2023-00687
• Device Sequence Number: 15638646
• Product Code: MCM
• UDI-Device Identifier: 09008737094089
• UDI-Public: (01)09008737094089
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 08/22/2024
• Device Model Number: MI1200 SYNCHRONY
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/03/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/20/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female