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

Model Number CI24RE(ST)

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Head Injury (1879); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Per the clinic, the device was explanted (specific date not reported) due to unspecific medical reason.Reimplantation is planned but has not taken place at the time of this report.

Event Description

Per the clinic, the patient experienced a performance decrement due to migration of the electrode array subsequent to sustaining a head trauma.The patient was re-implanted with another cochlear device on (b)(6) 2024.

• Brand Name: NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT 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: 18407552
• MDR Text Key: 331471401
• Report Number: 6000034-2023-04182
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024,01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2010
• Device Model Number: CI24RE(ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2024
• Distributor Facility Aware Date: 01/26/2024
• Date Report to Manufacturer: 01/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male