MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (ST)

Device Problem Extrusion (2934)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 05, 2018.

Event Description

It was reported that the patient's device was explanted on (b)(6) 2018 due extrusion of the electrode into the ear canal.The patient was reimplanted with another device during the same surgery.

• Brand Name: NUCLEUS 24K
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7662910
• MDR Text Key: 113154404
• Report Number: 6000034-2018-01342
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332(11)080903(17)100902
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2010
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2008
• 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