MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 17, 2021.

Event Description

Per the clinic, the patient developed an infection at the magnet site (date not reported) and subsequently was treated with topical steroids for 5 days and oral antibiotics for 1 month (specific date not reported).The device was explanted on (b)(6) 2021, due to partial extrusion of the implant in the anteroinferior end of the stimulator receptor.It is unknown if there are plans to reimplant the patient as of the date of this report.

Manufacturer Narrative

This report is submitted on october 15, 2021.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE 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: 12486409
• MDR Text Key: 271855054
• Report Number: 6000034-2021-02778
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)180514(17)200513
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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 Expiration Date: 05/13/2020
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention