MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

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

Patient Problems Unspecified Infection (1930); Pain (1994); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 17, 2020.

Event Description

Per the clinic, the patient developed an infection and experienced pain and drainage at the implant site, due to recurrent cholesteatoma.The patient was treated with oral and topical antibiotics (duration and specific date not reported).Explant is planned but has not taken place at the time of this report.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on november 13, 2020.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2020, re-implantation is planned but has not taken place as of the date of this report.This report is submitted on 15 september 2020.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10411920
• MDR Text Key: 203088093
• Report Number: 6000034-2020-02136
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)151027(17)171026
• 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,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2017
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention