MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24 ABI; NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM

Model Number ABI24M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced non-auditory stimulation resulting in loss of benefit.Consequently, the device was explanted (date not reported) and the patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted on march 13, 2023.

Manufacturer Narrative

Device analysis report is attached.This report is submitted on may 09, 2023.

• Brand Name: NUCLEUS 24 ABI
• Type of Device: NUCLEUS AUDITORY BRAINSTEM 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: 16527494
• MDR Text Key: 311126749
• Report Number: 6000034-2023-00849
• Device Sequence Number: 1
• Product Code: MHE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000015
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ABI24M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• 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 Sex: Male