MAUDE Adverse Event Report: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2024

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2024.The patient was re-implanted with another cochlear device during the same surgery.Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• MDR Report Key: 18719017
• MDR Text Key: 335521299
• Report Number: 6000034-2024-00561
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 02/16/2024,01/23/2024

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2024
• Distributor Facility Aware Date: 01/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male