MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (CS)

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Failure of Implant (1924); Nerve Damage (1979); Vertigo (2134); Neck Pain (2433); Implant Pain (4561)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 10, 2021.

Event Description

Per the clinic, the experienced vertigo and fluctuating hearing with the device use.It was also reported an impedance fluctuations on the apical electrodes causing facial nerve stimulation and some pain around implant and neck.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

The device was explanted on (b)(6) 2021.The patient was reimplanted with a new device during the same surgery.This report is submitted on nov 16, 2021.

Manufacturer Narrative

Device analysis report is attached.This report is submitted on january 25, 2022.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: yaneesa vetsandonphong ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12451943
• MDR Text Key: 270762218
• Report Number: 6000034-2021-02745
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 23 YR
• Patient Sex: Male