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

Model Number CI24RE(CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Skin Erosion (2075); Skin Infection (4544)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 16, 2022.

Event Description

The patient experienced a wound dehiscence and infection.The receiver/stimulator of the device was surgically re-positioned.It is unknown how the infection was treated.

Manufacturer Narrative

Correction: the date of event (b3) was filled incorrectly in the previous report, the event occurred in 2007 (specific date unknown).This report is submitted on october 06, 2022.

Manufacturer Narrative

Correction: the previous or initial mdr submitted on september 16, 2022, was filed inadvertently.Infection was reported by the patient and the infection is yet to be confirmed by healthcare professional.This report is submitted on december 04, 2022.

• Brand Name: NUCLEUS FREEDOM 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: belinder gill ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 15433701
• MDR Text Key: 300023603
• Report Number: 6000034-2022-02938
• Device Sequence Number: 1
• Product Code: MCM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 51 YR
• Patient Sex: Male