MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 12, 2023.

Event Description

Per the clinic, the patient experienced a skin breakdown at the implant site.The implanted device remains.Re-implantation is planned but has not taken place as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient also experienced skin necrosis and was treated with topical antibiotics for the infection.This report is submitted on april 4, 2024.

Manufacturer Narrative

Per the clinic, the patient also experienced an infection at the implant site.The device was explanted on (b)(6) 2024 and the patient was reimplanted with another cochlear device during the same surgery.Device analysis report attached.This report is submitted on february 28, 2024.

• Brand Name: NUCLEUS CI512 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: 18308427
• MDR Text Key: 330221336
• Report Number: 6000034-2023-03968
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)150423(17)170422
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2017
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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