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

Model Number CI24M

Device Problem Signal Artifact/Noise (1036)

Patient Problem Electric Shock (2554)

Event Date 06/21/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced poor performance and electric shock sensation with the device.Hardware exchange and reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023, and the patient was re-implanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted on july 26, 2023.

• 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17394665
• MDR Text Key: 319738833
• Report Number: 6000034-2023-02471
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 25 YR
• Patient Sex: Female