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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user complained of a change in sound quality and a sensation of a tickling in his right ear canal.The sound quality in the right ear has been reported as very high-pitched with a buzzing quality.Anyway the user still feels that hearing is better with the device than without it.The electrode array was then visualised in the user's ear canal, where an extrusion is suspected.The user will visit the implanting surgeon and a ct will be performed.

• 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: 15501076
• Report Number: 1066702-2022-00013
• Device Sequence Number: 5439072
• Product Code: MCM
• UDI-Device Identifier: 09008737371746
• UDI-Public: (01)09008737371746
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2022
• Report Date (Section F): 09/09/2022

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: Lay User/Patient
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 37180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR
• Patient Sex: Male