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 Problems Pain (1994); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 14 2019 by cochlear limited on behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient experienced pain and a skin ulcer at the magnet site following magnet dislodgement during an mri (tesla strength not reported) in (b)(6) 2018.Surgery to reposition the magnet has been scheduled; however, this has not occurred as of the date of this report.The implanted device remains.

Manufacturer Narrative

Additional: it has since been reported that the patient underwent a skin revision (date not reported); during the procedure the dislodged magnet was repositioned into the correct place.This report is submitted on april 17, 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: 8243064
• MDR Text Key: 132908017
• Report Number: 6000034-2019-00034
• 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
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2019
• 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?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention