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

Model Number CI512

Device Problem No Device Output (1435)

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

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on september 18, 2020.

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma.Explant is planned but has not yet taken place at the time of this report.

Manufacturer Narrative

It is reported that the device was explanted on (b)(6) 2020 and the patient was reimplanted with another cochlear device during the same surgery.This report is submitted on 19 oct 2020.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on december 21, 2020.

• 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, nsw 2109 ; AS 2109
• MDR Report Key: 10551786
• MDR Text Key: 207529452
• Report Number: 6000034-2020-02488
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)170728(17)190727
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2019
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 MO