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

Model Number CI512

Device Problems No Device Output (1435); Unexpected Therapeutic Results (1631)

Patient Problems Head Injury (1879); Hearing Impairment (1881); Failure of Implant (1924)

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on february 1, 2022.

Event Description

Per the clinic, the patient experienced a head trauma when she fell from her baby bicycle.She has since experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.There are plans to explant and re-implant the patient on (b)(6) 2022.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2022, and the patient was reimplanted with another cochlear device during the same surgery.This report is submitted on march 16, 2022.

Manufacturer Narrative

Device analysis indicated device failure.Device analysis report attached.This report is submitted on april 29, 2022.

• 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 13405991
• MDR Text Key: 284796142
• Report Number: 6000034-2022-00280
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)190911(17)210910
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2021
• Device Model Number: CI512
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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: 27 MO
• Patient Sex: Female