MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at implant incision site.The patient was treated with oral antibiotics (specific date and duration not reported); however, the issue did not resolve.The patient cultures returned positive for bacterial infection (h.Influenzae).Subsequently, the patient was hospitalized on (b)(6) 2023.During the admission, the patient was administered with iv antibiotics (duration not reported); however, this did not alleviate the problem resulting in a decision to explant the device.The device was explanted on (b)(6) 2023.Re-implantation is planned but had not taken place at the time of this report.

Manufacturer Narrative

Device analysis report attached.This report is submitted on september 20, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced wound dehiscence of the implant incision line (specific date not reported).Subsequently, the patient was treated with topical antibiotics on (b)(6) 2023 (specific duration not reported).However, this did not alleviate the problem and the patient underwent two surgical procedures on (b)(6) 2023 and (b)(6) 2023 respectively to drain the wound abscess.This report is submitted on april 24, 2024.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17778394
• MDR Text Key: 323784717
• Report Number: 6000034-2023-03024
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/28/2024

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 Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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; Hospitalization
• Patient Sex: Female