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  

Manufacturer Narrative

This report is submitted on september 4, 2023.

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.

Event Description

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.

Event Description

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

• 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
• MDR Report Key: 17675089
• MDR Text Key: 322600282
• Report Number: 6000034-2023-02924
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023,10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2023
• Distributor Facility Aware Date: 10/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female