MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Communication or Transmission Problem (2896)

Patient Problem Hearing Impairment (1881)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced a performance decrement with the device.Subsequently, the device was explanted on (b)(6) 2018 and the patient was reimplanted with another device during the same surgery.

Manufacturer Narrative

This report is filed on december 20, 2018.(b)(4).

• Brand Name: NUCLEUSCI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: tamara martin ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 8136497
• MDR Text Key: 129434342
• Report Number: 6000034-2018-02291
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)150701(17)170630
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

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: 06/30/2017
• Device Model Number: CI512
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR