MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (CA)

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 4, 2019.

Event Description

Per the surgeon, the device was explanted on (b)(6) 2019, due to the patient experiencing pain over the implant site resulting in device non-use.The patient was not reimplanted with another device.

Event Description

The device was explanted due to non-auditory percepts.The device passed all electrical tests confirming correct device function.

Manufacturer Narrative

This report is filed on february 24, 2020.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9407113
• MDR Text Key: 169005324
• Report Number: 6000034-2019-02645
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)080717(17)100716
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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 Expiration Date: 07/16/2010
• Device Model Number: CI24RE (CA)
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR