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

Model Number CI24M

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

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 7, 2020.

Event Description

Per the clinic, the patient experienced a performance decrement and facial nerve stimulation with device use.It was also reported that 4 electrodes were extra cochlear.The device was explanted on (b)(6) 2020, and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on 14 october 2020.

• Brand Name: NUCLEUS 24
• 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: 10498430
• MDR Text Key: 205883670
• Report Number: 6000034-2020-02383
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR