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

Model Number CI512

Device Problem Intermittent Loss of Power (4016)

Patient Problem Hearing Impairment (1881)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 25, 2018 by cochlear limited on behalf of cochlear americas.Exemption number (b)(4).

Event Description

Per the clinic, the patient experienced intermittencies with the internal device; however the issue could not be resolved.Explant and reimplantation is planned but has not taken place at the time of this report (b)(6) 2018.

Manufacturer Narrative

It is now reported that the device was explanted on (b)(6) 2018 and the patient was reimplanted with a new device during the same surgery.This report is filed on november 2, 2018.

• 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: 7904623
• MDR Text Key: 121562881
• Report Number: 6000034-2018-01912
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110228(17)130227
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2011
• 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: 12 YR