MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM,

Model Number CI24R (CS)

Device Problem No Device Output (1435)

Patient Problem Deafness (1801)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 3, 2019.

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains insitu.It is unknown whether the device will be explanted, as of the date of this report.

Manufacturer Narrative

The device was explanted on (b)(6) 2019.The recipient was re-implanted with a ci612 device.This report is submitted on october 28, 2019, by cochlear limited.

Event Description

The device was explanted on (b)(6) 2019, and the recipient was re-implanted with a ci612 device.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM,
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8958509
• MDR Text Key: 156386283
• Report Number: 6000034-2019-01688
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/04/2019,10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2019
• Distributor Facility Aware Date: 10/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR