MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Failure to Sense (1559)

Patient Problem Hearing Impairment (1881)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on july 24, 2019.

Event Description

Per the clinic, the patient experienced intermittencies and no sound.Integrity test results are consistent with a device malfunction.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with a new device as of the date of this report, july 24, 2019.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2019, and the patient was re-implanted with another cochlear device during the same surgery.This report is submitted september 16, 2019.

Manufacturer Narrative

This report is submitted december 18, 2019.- attachment: [153277 device analysis report reg.Pdf].

• Brand Name: NUCLEUS CI512 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: 8820022
• MDR Text Key: 152010900
• Report Number: 6000034-2019-01341
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110218(17)130217
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention