MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023 due to pain and discomfort.The patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 16710801
• MDR Text Key: 313002806
• Report Number: 6000034-2023-01135
• 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: 04/11/2023,03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2023
• Distributor Facility Aware Date: 03/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female