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 Bacterial Infection (1735); Necrosis (1971); Pain (1994); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 26, 2022.

Event Description

Per the clinic, the patient experienced an infection, skin breakdown, necrosis and pain at the implant site, exposing the receiver/stimulator (specific date not reported).It was reported that the patient was treated with oral, iv and topical antibiotics (specific date and duration not reported).Subsequently, the device was explanted on (b)(6) 2022.The patient also underwent a skin revision surgery (specific date not reported).There are no plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

Device analysis report attached.This report is submitted on september 27, 2022.

• 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15299657
• MDR Text Key: 298655315
• Report Number: 6000034-2022-02485
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)200729(17)220728
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: 07/28/2022
• Device Model Number: CI612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• 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): Required Intervention
• Patient Sex: Male