MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 30, 2020.

Event Description

Per the clinic, the patient experienced a magnet dislodgement during an mri (specific date not reported).Surgery to replace the magnet is scheduled, but has not yet taken place at the time of this report.

Manufacturer Narrative

The patient reported pain and crusting of the skin over the magnet approximately 2 weeks after the mri.The skin changes settled once the use of the device was stopped.The skin changes healed up and the magnet was then later repositioned (date unknown).This report is submitted on december 21, 2020.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: 10916435
• MDR Text Key: 218641442
• Report Number: 6000034-2020-03295
• 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: 12/01/2020

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 Expiration Date: 11/05/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/29/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 12/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention