MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problem Expulsion (2933)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2024, due to an extrusion of device.The patient was re-implanted with a new cochlear device on (b)(6) 2024, on the contralateral ear.

Manufacturer Narrative

This report is submitted on april 4, 2024.

Manufacturer Narrative

Per the clinic, the patient experienced a skin flap necrosis over the implant body.Device analysis report attached.This report is submitted on may 03, 2024.

• Brand Name: NUCLEUS CI24RE (CA) 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19038982
• MDR Text Key: 339318320
• Report Number: 6000034-2024-01233
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032636
• UDI-Public: (01)09321502032636(11)171214(17)191213
• 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: 04/05/2024

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: 12/13/2019
• Device Model Number: CI24RE(CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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 Age: 88 YR
• Patient Sex: Female