MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced migration of the electrode array resulting in the decision to explant the device.The device was explanted on (b)(6) 2019 and the patient was re-implanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on april 4, 2019.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• 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: 8392566
• MDR Text Key: 137924898
• Report Number: 6000034-2019-00245
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/01/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR