MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422 (Z409591)

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 25 sep 2020.

Event Description

Per the clinic, the recipient reported fall on the head and subsequently stopped responding to sound.Impedances measurement were performed and open circuit was observed on all electrodes.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

It has now been reported that the device was explanted (b)(6) 2021.This report is submitted on august 2, 2021.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• 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: 10584436
• MDR Text Key: 208531927
• Report Number: 6000034-2020-02609
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025706
• UDI-Public: (01)09321502025706(11)180910(17)200909
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2020
• Device Model Number: CI422 (Z409591)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention