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

Model Number CI24RE (ST)

Device Problem Migration (4003)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Skin Erosion (2075); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin breakdown (specific date not reported) and subsequently underwent a skin flap revision surgery on (b)(6) 2022.It was also reported that the patient experienced wound dehiscence and a migration of electrode array (specific date not reported).It was also reported that there is an infection at the implant site (specific date not reported) and the patient was subsequently treated with oral and topical antibiotics (specific date and duration not reported), to have the site cleaned, however, the issue could not be resolved.The implanted device remains.There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on september 15, 2022.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2022.It is unknown if there are plans to reimplant the patient as of the date of this report.This report is submitted on october 28, 2022.

Manufacturer Narrative

Per the clinic, the patient was also treated with antibiotics in (b)(6) 2022 (specific type, date and duration not reported) due to swelling at implant site.Device analysis report is attached.This report is submitted on november 28, 2022.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT 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: 15425436
• MDR Text Key: 299925609
• Report Number: 6000034-2022-02839
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)190319(17)210318
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/25/2022

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 Expiration Date: 03/18/2021
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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