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

Model Number CI622

Device Problem Expulsion (2933)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Tissue Breakdown (2681)

Event Date 04/30/2023

Event Type  Injury  

Event Description

Per the surgeon, the patient experienced a wound dehiscence and extrusion of the implant.The device was explanted on (b)(6) 2023.It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

This report is submitted on september 4, 2023.

Manufacturer Narrative

Per the clinic, the patient experienced an infection at the implant site (date not reported).Additional information has been requested but it has not been made available as of the date of this report.Device analysis report attached.This report is submitted on october 11, 2023.

Manufacturer Narrative

Correction: the previous or initial mdr submitted on october 11, 2023 was filed inadvertently.The patient did not experience infection.This report is submitted on october 30, 2023.

Manufacturer Narrative

This report is submitted on november 21, 2023.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17675090
• MDR Text Key: 322600330
• Report Number: 6000034-2023-02923
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)220804(17)240803
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2023

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: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/03/2023
• Supplement Dates Manufacturer Received: 09/20/2023; 10/17/2023; 10/31/2023
• Supplement Dates FDA Received: 10/11/2023; 10/30/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Female