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

Model Number CI24RE (ST)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Swelling (2091); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 20, 2019.

Event Description

Per the clinic, the patient experienced inflammation, swelling and an infection at the implant site that was treated with antibiotics (oral and iv).The device was explanted (b)(6) 2019.It is unknown if the patient has been re-implanted with another device.

Manufacturer Narrative

This report is submitted on 30 january 2020.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9501500
• MDR Text Key: 173910577
• Report Number: 6000034-2019-02829
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032643
• UDI-Public: (01)09321502032643(11)180110(17)200109
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2020
• Device Model Number: CI24RE (ST)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention