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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on june 17, 2019.

Event Description

Per the clinic, the patient was treated with oral antibiotics for pain and swelling at the implant site.The device remains in-situ.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2019, and the patient was re-implanted with another cochlear device during the same surgery.This report is submitted september 16, 2019.

Manufacturer Narrative

Analysis of device indicates a device failure.This report is submitted 25 october 2019.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8702705
• MDR Text Key: 148140070
• Report Number: 6000034-2019-01030
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 10/01/2019
• Supplement Dates FDA Received: 09/15/2019; 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention