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

Model Number CI24R(CS)

Device Problem Output Problem (3005)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/23/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced poor performance with the device use.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2022 and the patient was reimplanted with a new device during the same surgery.

• Brand Name: NUCLEUS 24 CONTOUR
• 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: 15071393
• MDR Text Key: 296287872
• Report Number: 6000034-2022-02111
• 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: 07/21/2022,06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R(CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Distributor Facility Aware Date: 06/29/2022
• Date Report to Manufacturer: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female