MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 28, 2022.

Event Description

Per the clinic, the patient experienced poor performance and pain with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted under a general anaesthetic on (b)(6) 2022.It is unknown if the patient was re-implanted with another device.

Event Description

Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2022-00580.

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 13615963
• MDR Text Key: 286224830
• Report Number: 6000034-2022-00520
• Device Sequence Number: 1
• Product Code: MCM
• 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,Followup
• Report Date: 04/22/2022,04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2022
• Distributor Facility Aware Date: 04/06/2022
• Date Report to Manufacturer: 04/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female