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

Model Number CI22M

Device Problems High impedance (1291); No Device Output (1435)

Patient Problem No Code Available (3191)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

This report is submitted onnovember 18, 2019.

Event Description

Per the clinic, the patient experienced a trauma over the implant site resulting in high impedances and open circuits on all the electrodes.

Manufacturer Narrative

This report is submitted on 27 march 2020.(b)(4).

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2019 and the patient was re-implanted with a new device during the same surgery.This report is submitted 3 february 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: 9333632
• MDR Text Key: 166741494
• Report Number: 6000034-2019-02578
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025706
• UDI-Public: (01)09321502025706(11)180621(17)200620
• Combination Product (y/n): N
• PMA/PMN Number: P890027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2020

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: 06/20/2020
• Device Model Number: CI22M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/17/2019
• Supplement Dates Manufacturer Received: 01/07/2020; 03/03/2020
• Supplement Dates FDA Received: 02/02/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR