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

Model Number CI422

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2019

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient experienced no hearing outcome with device use due to a non-device related medical issue.Subsequently, the device was explanted on (b)(6) 2019.The patient was not reimplanted as of the date of this report.

Manufacturer Narrative

This report is submitted 10 july 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: 10136585
• MDR Text Key: 194601453
• Report Number: 6000034-2020-01460
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)131209(17)151208
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2015
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR