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 04/09/2019

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies with the internal device, however, the issue could not be resolved.The implanted device remains and the patient is being clinically managed by the health care provider.

Manufacturer Narrative

Returned device received at cochlear on july 24, 2019.As per the document returned with the device, the device was explanted on (b)(6), 2019, and the patient was reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

This report is submitted september 19, 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: 8229936
• MDR Text Key: 132507345
• Report Number: 6000034-2018-02523
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110603(17)130602
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2013
• Device Model Number: CI512
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Distributor Facility Aware Date: 07/24/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR