MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI612

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at implant site and subsequently was treated with oral and topical antibiotics (specific date and duration not reported).The patient was also hospitalized on (b)(6) 2023, for a duration of three days.During the admission, the patient was administered with iv antibiotics.Subsequently, on (b)(6) 2023, the patient was placed under general anesthesia in order to undergo skin debridement and device repositioning surgery.The implanted device remains.

Manufacturer Narrative

This report is submitted on december 27, 2023.

• Brand Name: NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18396466
• MDR Text Key: 331357629
• Report Number: 6000034-2023-04128
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• UDI-Public: (01)09321502036818(11)220727(17)240726
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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
• Report Date: 11/30/2023

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: CI612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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; Hospitalization
• Patient Sex: Female