MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problem Unspecified Ear or Labyrinth Problem (4474)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

This report has been submitted on 15 december 2020.

Event Description

Per the clinic, the device was explanted on (b)(6) 2020 due to suspected device failure and loss of electrode function.The patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted on 19 april 2021.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: 11010410
• MDR Text Key: 221484678
• Report Number: 6000034-2020-03443
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502025690
• UDI-Public: (01)09321502025690(11)190306(17)210305
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2021
• Device Model Number: CI24RE(CA)
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR