MAUDE Adverse Event Report: COCHLEAR LIMITED 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.

Manufacturer Narrative

This report is submitted on july 21, 2022.

Manufacturer Narrative

Device analysis report attached.This report is submitted on october,02, 2022.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: belinder gill ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15071394
• MDR Text Key: 296287988
• Report Number: 6000034-2022-02110
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female