MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Bacterial Infection (1735)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 23, 2019.

Event Description

Per the clinic, the patient experienced migration of the electrode array and infection which was treated with oral antibiotics.The issue could not be resolved resulting in the decision to explant the device on (b)(6) 2019.There are no plans to re-implant the patient with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted october 29, 2019.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9102201
• MDR Text Key: 160490728
• Report Number: 6000034-2019-01898
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)120910(17)140909
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2014
• 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
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR