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

Model Number CI24R (ST)

Device Problems Device Operational Issue (2914); Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted june 25, 2018.

Event Description

Per the clinic, the patient experienced intermittent abnormal auditory sensations.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2018.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

Additional: it has since been reported that the patient was reimplanted with a new device.This report is submitted on april 5, 2019.

• 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
• MDR Report Key: 7632807
• MDR Text Key: 112137306
• Report Number: 6000034-2018-01323
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR