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

Model Number CI24RE (CA)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on december 30, 2019.

Event Description

Per the clinic, the patient experienced pain with stimulation.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is filed on february 20, 2020.

• Brand Name: NUCLEUS FREEDOM 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: 9533529
• MDR Text Key: 173251983
• Report Number: 6000034-2019-02957
• 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: 12/30/2019,01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2019
• Date Report to Manufacturer: 12/09/2019
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR