MAUDE Adverse Event Report: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on february 16, 2024.

Event Description

Per the clinic, the patient experienced a magnet dislodgement during an mri (1.5 tesla).The patient's head was wrapped as recommended by cochlear.The patient experienced a sore at magnet site and subsequently was treated with topical antibiotics (specific date and duration not reported).Surgery under iv sedation has been completed on (b)(6) 2024, in order to replace the magnet.The implanted device remains.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• MDR Report Key: 18718251
• MDR Text Key: 335582063
• Report Number: 6000034-2024-00541
• 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
• Report Date: 01/23/2024

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: 10/31/2020
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female