MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Expulsion (2933)

Patient Problems Post Operative Wound Infection (2446); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Device analysis report attached.This report is submitted on november 30, 2023.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, due to extrusion of the receiver/stimulator.There are no plans to re-implant the patient with a new device as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient experienced a wound infection and underwent two different procedures, the first on (b)(6) 2023 for wound closure, however, the issue did not resolved.Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported) and hospitalized from (b)(6) 2023 until (b)(6) 2023 for administration of iv antibiotics.The second revision surgery was performed on (b)(6) 2023 to close the wound.This report is submitted on december 29, 2023.

Manufacturer Narrative

Per the clinic, the patient was placed under general anesthesia during two different procedures on (b)(6) 2023 and (b)(6) 2023.This report is submitted on february 06, 2024.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; 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: 18235151
• MDR Text Key: 329314052
• Report Number: 6000034-2023-03825
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)220621(17)240620
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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