MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI624 PROFILE PLUS WITH SLIM 20 ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI624

Device Problem Malposition of Device (2616)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 23, 2021.

Event Description

Per the audiologist, the patient experienced non-auditory stimulation with device use.Reprogramming attempts were unsuccessful in alleviating the issue.A ct scan revealed that the electrode array was outside of the cochlea.The device was explanted on (b)(6) 2021, and the patient reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on 7 may 2021.

• Brand Name: NUCLEUS CI624 PROFILE PLUS WITH SLIM 20 ELECTRODE
• 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: 11548301
• MDR Text Key: 241691796
• Report Number: 6000034-2021-00833
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)200117(17)220116
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2022
• Device Model Number: CI624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR