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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Irritation (1941)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 9 january 2020.

Event Description

Per the clinic, the device was explanted on (b)(6) 2019 due to chronic irritation and keloids at implant site.The patient was re-implanted with a new device during the same surgery.

• Brand Name: Nucleus
• 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: 9566883
• MDR Text Key: 174262751
• Report Number: 6000034-2020-00166
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)130704(17)150703
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2020,12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2015
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2020
• Distributor Facility Aware Date: 12/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR