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

Model Number OSI200

Device Problems Circuit Failure (1089); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hearing Impairment (1881)

Event Type  malfunction  

Event Description

Per the clinic, open circuits were noted on nine electrodes.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

Manufacturer Narrative

This report is submitted on november 01, 2022.

Manufacturer Narrative

There is now a reported device failure and explant on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.This report is submitted on may 12 2023.

• Brand Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: thevamalar jayamagentharan ; 1 university avenue; no. 8 jalan kerinchi,; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 15705395
• MDR Text Key: 302827844
• Report Number: 6000034-2022-03166
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2022
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female