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

Model Number CI622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 31, 2023.

Event Description

Per the clinic, the patient experienced pain, swelling and a burning sensation at the implant site.The patient has an infection at the implant site that was treated with antibiotics.There are plans to explant and re-implant the device.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023.There are no plans to reimplant the patient with a new device as of the date of this report.

• 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: 16269344
• MDR Text Key: 308439116
• Report Number: 6000034-2023-00292
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)210809(17)230808
• 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
• Report Date: 03/17/2023,02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2023
• 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: 03/17/2023
• Distributor Facility Aware Date: 02/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female