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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Insufficient Information (4580)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
Device was explanted due to unknown reason on (b)(6) 2021.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.This finding was expected, because according to the recipient report the device was explanted for medical reasons, namely extrusion of the device through the skin.Reportedly a swelling was present prior to the extrusion, which might be a hint for infection.However no information on a possible infection was received.A review of the devices 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 the possible infection.This is a final report.
Event or Problem Description
Device was explanted on (b)(6), 2021 due to extrusion of the device through the skin.An extrusion was first seen on the (b)(6) 2020.Before device extrusion the hearing performance with the device was good.The user was re-implanted.

• 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: 11221470
• Report Number: 9710014-2021-00037
• Device Sequence Number: 3740021
• Product Code: MCM
• UDI-Device Identifier: 09008737093983
• UDI-Public: (01)09008737093983
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 01/25/2021

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 Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/24/2021
• 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: Required Intervention
• Patient Age: 63 YR