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

Model Number FREEDOM H6

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  Injury  

Manufacturer Narrative

This report is submitted on nov 20, 2023.

Event Description

Per the clinic, 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.The patient was re-implanted with a new device in the same procedure.

• Brand Name: COCHLEAR IMPLANT, FREEDOM H6
• Type of Device: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 18167313
• MDR Text Key: 328476842
• Report Number: 6000034-2023-03688
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2023

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: FREEDOM H6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male