MAUDE Adverse Event Report: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Hardware exchange and troubleshooting 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

This report is submitted on february 16, 2024.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2024 and the patient was reimplanted with another device during the same surgery.Device analysis indicated device failure.Device analysis report attached.This report is submitted on may 13, 2024.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• MDR Report Key: 18718619
• MDR Text Key: 335931882
• Report Number: 6000034-2024-00578
• Device Sequence Number: 1
• Product Code: MCM
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2021
• 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; Other
• Patient Age: 4 YR
• Patient Sex: Male