MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM, PRODUCT CODE:

Model Number CI512

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced magnet dislodgement during an mri.The implanted device remains.The plan is for the patient to be contacted by his scheduler for the procedure to address the displaced magnet as nothing is yet scheduled as of the time of this report.

Manufacturer Narrative

This report is filed on february 6, 2020.

Event Description

The original magnet was placed back into the magnet socket under a general anaesthetic.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM, PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9243442
• MDR Text Key: 163891931
• Report Number: 6000034-2019-02206
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)181112(17)201111
• 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: 02/06/2020,01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2020
• Device Model Number: CI512
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2020
• Distributor Facility Aware Date: 10/04/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/14/2020
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention