MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24M

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

Patient Problems Wound Dehiscence (1154); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 16, 2020.

Event Description

Per the clinic, the patient experienced skin breakdown at the implant site.The device was explanted on (b)(6) 2020.There are plans to re-implant the patient at a later date.

Event Description

It was reported that prior to explant the patient experienced an infection.

Manufacturer Narrative

This report is submitted on 17 july 2020.

• Brand Name: NUCLEUS 24
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 10160591
• MDR Text Key: 195366220
• Report Number: 6000034-2020-01516
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/17/2020,06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Distributor Facility Aware Date: 06/24/2020
• Date Report to Manufacturer: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention