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

Model Number CI24RE (CA)

Device Problem Circuit Failure (1089)

Patient Problems Fall (1848); Head Injury (1879); Failure of Implant (1924)

Event Type  Injury  

Event Description

Per the clinic, the patient sustains a head trauma due to a fall on (b)(6) 2021 and became non-stimulable to sound.It was reported that open circuits was noted in all electrodes.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Per the clinic, the device was explanted on (b)(6) 2021 and the patient was re-implanted with another cochlear device during the same surgery.

• 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: 12833832
• MDR Text Key: 280927119
• Report Number: 6000034-2021-03488
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)120121(17)140120
• 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: 12/09/2021,11/17/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2021
• Distributor Facility Aware Date: 11/17/2021
• Date Report to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male