MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE (ST)

Device Problem Circuit Failure (1089)

Patient Problem Fall (1848)

Event Date 10/30/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 16, 2021.

Event Description

Per the clinic, the patient experienced a fall (specific date not reported) and impedance measurements revealed open circuits on multiple electrodes except e17.Subsequently, the device was explanted on (b)(6) 2021 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

It was reported that the patient had skin excised during explant surgery on (b)(6) 2021.This report is submitted on december 29, 2021.

Manufacturer Narrative

Device analysis report attached.This report is submitted on january 25, 2022.

• Brand Name: NUCLEUS FREEDOM COCHLEAR IMPLANT WITH STRAIGHT 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: debbie ang ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12818079
• MDR Text Key: 280801674
• Report Number: 6000034-2021-03505
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/07/2021; 01/19/2022
• Supplement Dates FDA Received: 12/29/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 20 YR
• Patient Sex: Female