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

Model Number CI522

Device Problem Insufficient Information (3190)

Patient Problems Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 20, 2021.

Event Description

It was reported the device was explanted (specific date not reported), due to an unknown reason.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient experienced a skin flap infection and subsequently was treated with antibiotics for 1.5 years (type and specific date not reported).This report is submitted on august 20, 2021.

Manufacturer Narrative

This report is submitted on september 15, 2021.

• 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; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 12194204
• MDR Text Key: 262413181
• Report Number: 6000034-2021-02162
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180518(17)200517
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2021

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: 05/17/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 08/03/2021; 08/25/2021
• Supplement Dates FDA Received: 08/20/2021; 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention