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

Model Number CI422

Device Problem High impedance (1291)

Patient Problem Hearing Impairment (1881)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 17, 2020.

Event Description

Per the clinic, the patient experienced high impedances.After medical assessment the clinical team decided to explant the device because the electrode array was out of the cochlea.The device was explanted on (b)(6) 2020.It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on may 11, 2020.

• 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, 2109 ; AS 2109
• MDR Report Key: 9838800
• MDR Text Key: 183703978
• Report Number: 6000034-2020-00719
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)190118(17)210117
• 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: 04/22/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2021
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 05/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO