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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Meningitis (2389)
Date of Event	03/05/2020
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
Around one month after implantation surgery the recipient developed fever and was feeling sick, was tested for the flu but then recovered.On the (b)(6) 2020 the same symptoms occurred, sickness and high fever.The user was admitted to hospital and diagnosed with meningitis, then recovered and was released on (b)(6).The device has not been worn since being admitted to hospital.Due to the re-occurrence of meningitis, the user was explanted on the (b)(6) 2020.
Event or Problem Description
Around one month after implantation surgery the recipient developed fever and was feeling sick.They were tested for the flu but then recovered.On the (b)(6) 2020 the same symptoms occurred, sickness and high fever.The user was admitted to hospital and diagnosed with meningitis, then recovered and was released on the 15th march.The device has not been worn since being admitted to hospital.Due to the re-occurrence of meningitis, the user was explanted on the (b)(6) 2020.There are no plans for re-implantation.
Additional Manufacturer Narrative
Conclusion: according to the information received, the recipient has a history of post-operative recurrent meningitis episodes.Congenital inner ear anomalies, such as the reported mondini dysplasia, bear an inherent risk of recurrent meningitis even without a history of otosurgery, due to a fistulous connection between the cerebrospinal fluid spaces and the middle ear.Further, the observed intraoperative cerebrospinal fluid leak represents a known risk factor for bacterial meningitis.However, a ci procedure in these cases might further increase the risk of ascending infection.Additionally, according to the information received, moderate ossification was observed both pre- and intra-operatively, however, full insertion was reported.Cochlear ossification occurs as a sequela of inflammation of the inner ear following meningitis and is progressive from the base to the apex, thus possibly explaining the slightly elevated impedances observed in the present case on some basal channels.The concerned device was explanted but is not available for investigation.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
• MDR Report Key: 9864315
• Report Number: 9710014-2020-00192
• Device Sequence Number: 3267496
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 05/22/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 4 YR