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

Model Number CI22M

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hearing Impairment (1881)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 15 ocotber 2020.

Event Description

Per the clinic, it was reported that the patient experienced pain and poor performance with the device from onset.Subsequently, the device was explanted on (b)(6) 2020.It i unknown whether the patient was reimplanted, as of the date of this report.

Manufacturer Narrative

This report is submitted on 23 november 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: 10681626
• MDR Text Key: 211433332
• Report Number: 6000034-2020-02835
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P840024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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: 10/01/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR