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

Model Number CI612

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Event Description

Per the clinic, the patient experience a wound dehiscence and skin erosion over the implant site, exposing the receiver/stimulator.Explant is planned but has not taken place at the time of this report.

Manufacturer Narrative

This report is submitted on march 07, 2023.

Event Description

The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.

Manufacturer Narrative

The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.This report is submitted on april 24, 2023.

Manufacturer Narrative

It was reported that the patient was treated with oral antibiotics (duration not reported).Device analysis report is attached.This report is submitted on june 13, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced infection at the implant site.This report is submitted on may 18, 2023.

• Brand Name: NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16493123
• MDR Text Key: 310773256
• Report Number: 6000034-2023-00688
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)220518(17)240517
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 05/19/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2024
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/02/2023
• Date Report to Manufacturer: 04/02/2023
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 04/28/2023; 05/19/2023
• Supplement Dates FDA Received: 04/23/2023; 05/17/2023; 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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): Required Intervention
• Patient Sex: Female