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

Model Number CI522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Swelling (2091)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 13, 2018.

Event Description

Per the clinic, the patient experienced swelling of the skin flap and subsequently on (b)(6) 2018 the patient was treated with a steroid injection and oral antibiotics for a week.On (b)(6) 2018 the patient was once again treated with a steroid injection and oral antibiotics for 4 days.It was reported that the patient experienced skin breakdown.The patient was hospitalized on (b)(6) 2018 and underwent skin revision.Revision surgery to explant the device and reimplant the contralateral side is scheduled, however, it has not occurred as of the date of this report.

Manufacturer Narrative

It is now reported that the device was explanted on (b)(6) 2018.This report is filed on november 2, 2018.

Manufacturer Narrative

It is now reported that the reason for explanting the device was due to infection.This report is filed on november 20, 2018.

Manufacturer Narrative

This report is filed on november 29, 2018.(b)(4).

• 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
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7871862
• MDR Text Key: 120098404
• Report Number: 6000034-2018-01836
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180220(17)200219
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 MO