MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R(ST)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on 27 april 2020.

Event Description

Per the clinic, the device was explanted on (b)(6) 2019 due to acute mastoiditis.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.

• Brand Name: NUCLEUS 24K
• 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: 9999543
• MDR Text Key: 188974445
• Report Number: 6000034-2020-01122
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24R(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR