MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on october 10, 2023.

Event Description

Per the clinic, the patient experienced pain, a "pang of current" and no sound during stimulation.Troubleshooting attempts were made; however, the issue could not be resolved.Subsequently, the device was explanted on (b)(6) 2023.It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report attached.This report is submitted on november 29, 2023.

• Brand Name: NUCLEUS 22
• 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: mastura ruhanet ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17902210
• MDR Text Key: 325231889
• Report Number: 6000034-2023-03356
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P840024
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• 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: 31 YR
• Patient Sex: Female