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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Failure of Implant (1924); Tissue Breakdown (2681)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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 recipient is planned to be explanted due to electrode extrusion through the tympanic membrane and non-use.The recipient never had benefit from the device due to cystic cochlea deformity and cochlear nerve deficiency.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 attributable to the removal surgery.According to the information received from the field the device was explanted due to an extrusion of the electrode lead into the external ear canal.Further it is reported that the recipient was a non-user due to no benefit.Reportedly the lack of benefit was caused by device unrelated medical reasons namely cystic cochlea deformity and cochlear nerve deficiency.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The electrode lead extruded through the tympanic membrane.The device was explanted on (b)(6) 2020.

• 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: 10599679
• Report Number: 9710014-2020-00556
• Device Sequence Number: 3649786
• Product Code: MCM
• UDI-Device Identifier: 09008737094089
• UDI-Public: (01)09008737094089(11)160722(17)190722
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: Required Intervention
• Patient Age: 3 YR