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

Model Number CI22M

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on juine 15, 2020.

Event Description

Per the clinic, it was reported that the device was explanted on (b)(6) 2018, due to lack of benefit with the device.It is unknown whether the patient was reimplanted, as of the date of this report.

Manufacturer Narrative

This report is submitted on 8 july 2020.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10151510
• MDR Text Key: 195077688
• Report Number: 6000034-2020-01464
• Device Sequence Number: 1
• Product Code: MCM
• 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
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• 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: 37 YR