MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on march 9, 2020.

Event Description

Per the clinic, the patient experienced a magnet dislodgement during an mri (1.5 tesla) on an unknown date.The patient's head was not wrapped as recommended by cochlear.The magnet was replaced on an unknown date.The device was explanted on (b)(6) 2020 because the magnet had dislodged again.The patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on jun 22, 2021.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR 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: 9803998
• MDR Text Key: 182510368
• Report Number: 6000034-2020-00586
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)170125(17)190124
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/09/2020,05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2019
• Device Model Number: CI532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2020
• Date Report to Manufacturer: 02/11/2020
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention