MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS HYBRID H6; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (H6)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on dec 15, 2023.

Event Description

Per the surgeon, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023.

• Brand Name: NUCLEUS HYBRID H6
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 18332467
• MDR Text Key: 330545497
• Report Number: 6000034-2023-03997
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023,11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (H6)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2023
• Distributor Facility Aware Date: 11/21/2023
• Date Report to Manufacturer: 11/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female