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

Model Number CI422

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

Patient Problems Head Injury (1879); Hematoma (1884); Unspecified Infection (1930)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 3, 2020.

Event Description

Per the clinic, the patient developed a hematoma and infection at the implant site, subsequent to sustaining a head trauma.The patient was treated with oral antibiotics (specific duration not reported), and the device was explanted on (b)(6) 2020.The patient has not been reimplanted with a new device as of this report.

Manufacturer Narrative

This report is submitted on december 23, 2020.

Manufacturer Narrative

There is a correction of the device serial number that was explanted.This report is submitted on december 4, 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, nsw 2109 ; AS 2109
• MDR Report Key: 10776353
• MDR Text Key: 214304139
• Report Number: 6000034-2020-02947
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)181214(17)201213
• 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,Followup
• Report Date: 12/04/2020

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: 09/26/2019
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 12/04/2020
• Supplement Dates FDA Received: 12/04/2020; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 MO