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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Meningitis (2389)
Date of Event	10/21/2018
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
The user is reported to have had meningitis several times.The device was explanted to allow for high resolution mri.No product deficiency is alleged.
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 most likely related to the explantation surgery.This finding was expected because according to the information received from the field the device was explanted due to several occasions of meningitis and the need of a magnet resonance imaging.However, despite requested, no information has been received on the recipient_s vaccination status, treatment, etiology (which organism was involved), timeline of meningitis incidents, possible other device unrelated factors.Nevertheless, a history of meningitis itself, is a predisposing risk factor for meningitis.In addition, cochlear implants themselves increase the risk of bacterial meningitis especially during the first 2 months after implantation (lorry g.Rubin, cochlear implants in children, pediatrics 2010;vol 126, number 2).Further the device was explanted five years after implantation and a review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of infection.A definite cause for the reported incident could not be determined due to lack of information.The investigation results appear to match the problems mentioned in the report.This is a final report.
Event or Problem Description
The recipient is reported to have had meningitis several times.The device was explanted to allow for high resolution mri.No further information has been received, despite requested.

• 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: 8041063
• Report Number: 9710014-2018-00906
• Device Sequence Number: 1585259
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Ten-Day
• Initial Date Received by Manufacturer: 11/04/2018
• Supplement Date Received by Manufacturer: 11/04/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 07/29/2019
• 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: 10 YR