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 Problems High impedance (1291); Migration (4003)

Patient Problems Ossification (1428); Pain (1994)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced increasing impedances, electrode migration and pain.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023.The patient was re-implanted with a new device in the same procedure.

Manufacturer Narrative

This report is submitted on may 4, 2023.

Manufacturer Narrative

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023.This report is submitted on may 11, 2023.

Manufacturer Narrative

Correction: the correct patient identifier is (b)(6) as previously reported.The correct date of birth is on (b)(6) 2011; not on (b)(6) 2010 as previously reported.This report is submitted on june 19, 2023.

• 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: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16865998
• MDR Text Key: 314523956
• Report Number: 6000034-2023-01378
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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