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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Meningitis (2389)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the device has been explanted.The user had 3 post-operative episodes of meningitis ((b)(6) 2022) for which he had to be hospitalized each time and treated accordingly.It was then decided to perform revision surgery and to remove the device.Reportedly, a ct scan showed an anomaly (common cavity).An transorbital x-ray showed the electrode inside the cochlea.
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
Information was received that the device had been explanted.The user had 3 post-operative episodes of meningitis ((b)(6) 2022) for which he had to be hospitalized each time and treated accordingly.It was then decided to perform revision surgery to remove the device.The user was discharged from the clinic and the user's health improved.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received, the recipient was explanted due to a history of pre- and post-operative recurrent meningitis episodes.Congenital inner ear anomalies, such as the reported common cavity deformity, bear an inherent risk of recurrent meningitis even without a history of otosurgery, as observed in the present case.Further, intra-operative cerebrospinal fluid leakage represents a known risk factor for pneumococcal meningitis.In conclusion, considering the early post-operative onset and the preexisting congenital deformity, the reported event was likely due to a combination of surgical and anatomical factors.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 infection.However, a device contribution to the subsequent development of the infection cannot be ruled out.This is a final report.

• 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: 15689358
• Report Number: 9710014-2022-00821
• Device Sequence Number: 20672410
• 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: 2022
• 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): 02/27/2023

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: 03/05/2023
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• 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: 23 MO
• Patient Sex: Unknown