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 Abscess (1690); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the clinic, the patient was hospitalized from (b)(6) 2023 to (b)(6) 2023 due to an infection at the implant site.Subsequently, the patient underwent a surgical drainage procedure on (b)(6) 2023 and was treated with iv antibiotics for 15 days.However, the issue could not be resolved.The patient was hospitalized again from (b)(6) 2023 to (b)(6) 2023 and underwent surgical drainage procedure (date not reported) for the second time.The patient was treated again with iv antibiotics for another 15 days.It was also reported that a furuncle (abscess) has developed at the implant site.Subsequently, the device was explanted on (b)(6) 2023.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

Manufacturer Narrative

This report is submitted on september 08, 2023.

Manufacturer Narrative

This report is submitted on october 27, 2023.

• 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17708988
• MDR Text Key: 322924107
• Report Number: 6000034-2023-02900
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)220223(17)240222
• 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
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2024
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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