MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 2, 2019.

Event Description

Per the clinic, the patient experienced facial nerve stimulation and poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on march 31, 2020.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9508889
• MDR Text Key: 172371839
• Report Number: 6000034-2019-02885
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P840024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR