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 01/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced intermittencies with device use.Reprogramming attempts were made; however, the issue could not be resolved.Reimplantation is planned but had not taken place at the time of this report.

Manufacturer Narrative

It was reported the device was explanted on (b)(6) 2019 and the patient was re-implanted with a new device during the same surgery.This report is filed on may 01, 2019.

• 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
• MDR Report Key: 8309106
• MDR Text Key: 135150205
• Report Number: 6000034-2019-00110
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110302(17)130301
• 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
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR