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

Model Number CI512

Device Problems Circuit Failure (1089); Device Fell (4014)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on july 26, 2023.

Event Description

Per the clinic, the patient experienced open mp2 and pain with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2023.The surgeon accidentally snipped ground electrode hence, the pin portion and about 4mm of lead which fell inside could not be located was left in patient.The patient was subsequently reimplanted with another cochlear device during the same surgery.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report attached.This report is submitted on january 12, 2024.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: mastura ruhanet ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17394677
• MDR Text Key: 319738475
• Report Number: 6000034-2023-02427
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)160530(17)180529
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/29/2018
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• 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 Sex: Female