MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS HYBRID S8; NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (S8)

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/16/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced skin irritation at the implant site.The device was explanted on (b)(6) 2020.There are no plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on 19 january 2021.

Event Description

It was reported that prior to explant the patient experienced infection at implant site.

• Brand Name: NUCLEUS HYBRID S8
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11144335
• MDR Text Key: 225995056
• Report Number: 6000034-2021-00138
• Device Sequence Number: 1
• Product Code: PGQ
• 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: 01/19/2021,01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (S8)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2021
• Distributor Facility Aware Date: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR