MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Undesired Nerve Stimulation (1980)

Event Date 07/15/2020

Event Type  Injury  

Event Description

Per the audiologist, the patient experienced non-auditory stimulation with device use.Reprogramming attempts were unsuccessful in alleviating the issue.The device was explanted on (b)(6) 2020.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.

Event Description

Per the clinic, the patient had a chronic infection with a fistula behind ear.

Manufacturer Narrative

Per the clinic, the patient had a chronic infection with a fistula behind ear.This report is submitted on november 9, 2020.

• Brand Name: NUCLEUS CI612 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: 10435204
• MDR Text Key: 203798546
• Report Number: 6000034-2020-02196
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)190828(17)210827
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/09/2020,10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2021
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2020
• Distributor Facility Aware Date: 10/19/2020
• Date Report to Manufacturer: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR