MAUDE Adverse Event Report: COCHLEAR LTD ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced mrsa infection at the implant site.Subsequently, the device was explanted on (b)(6) 2024 and there are plans to re-implant the patient with a new device once the infection has cleared.

• Brand Name: ASKU
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 18863009
• MDR Text Key: 337179226
• Report Number: 6000034-2024-00802
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024,02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2024
• Distributor Facility Aware Date: 02/12/2024
• Date Report to Manufacturer: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male