MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Staphylococcus Aureus (2058)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 18, 2019.

Event Description

Per the clinic, the patient developed an (b)(6) infection at the implant site.Treatment with oral antibiotics were unsuccessful, resulting in extrusion of the receiver stimulator due to erosion of the tissue over the implant site.Subsequently, the device was explanted on (b)(6) 2019.The patient was not reimplanted with another device due to the infection.The patient continued the course of oral antibiotics, and the infection has since healed.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 16 april 2020.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR 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: 9484712
• MDR Text Key: 173905075
• Report Number: 6000034-2019-02823
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)180724(17)200723
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR