MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR IMPLANT MODEL CI612; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 28 october 2019.

Event Description

Per the clinic, the patient experienced nausea and pain at implant site; subsequently the patient was treated with steroid injections (date and duration not reported).

Manufacturer Narrative

It was reported the patient experienced infection at implant site.This report is submitted on 20 november 2019.

• Brand Name: COCHLEAR IMPLANT MODEL CI612
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9243457
• MDR Text Key: 163894362
• Report Number: 6000034-2019-02382
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)190726(17)210725
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2021
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention