MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Electrical Shorting (2926)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, short circuits were noted on multiple electrodes.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on december 01, 2023.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2023.Reimplantation is planned but had not taken place at the time of this report.This report is submitted on january 02, 2024.

Manufacturer Narrative

Per the clinic, it was also reported that the patient was reimplanted with another cochlear device on (b)(6) 2023.This report is submitted on april 04, 2024.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR 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: ashwinii chelvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18244347
• MDR Text Key: 329450859
• Report Number: 6000034-2023-04002
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)230816(17)250815
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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; Other