MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS 24K; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24R (ST)

Device Problem Expulsion (2933)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 22, 2020.

Event Description

Per the clinic, it was reported that the patient experienced an extrusion of the electrode array through the tympanic membrane subsequent to a non-device related infection.It is unknown whether there are plans to explant the device, as of the date of this report.

Manufacturer Narrative

Correction: the previous mdr submitted on (b)(6) 2021 was filed inadvertently.No explantation or serious injury has occurred, the device remains in-situ.This report is submitted on 9 february 2021.

Manufacturer Narrative

It was reported that the device was explanted on (b)(6) 2020 and the patient was re-implanted with a new device during the same surgery.This report is submitted on 12 january 2020.

Manufacturer Narrative

There is more information on the device evaluation.Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Customer does not know how the device lid was cracked.The staff is trained and experienced in the use of the device.The device history record review confirmed that device conformed to specifications at the time of shipping.There is no repair history for this device.The cause of the suggested event cannot be conclusively determined.It is likely that the user made a scope or something hard come in contact with the lid.The user can detect the event by inspecting equipment in accordance with the following instructions for use statement; chapter 3 inspection before use, 3.2 inspecting the lid and lid packing before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.

Manufacturer Narrative

Device analysis report attached.This report is submitted on november 01, 2021.

• Brand Name: NUCLEUS 24K
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 10306056
• MDR Text Key: 199822436
• Report Number: 6000034-2020-01885
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502002332
• UDI-Public: (01)09321502002332
• 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,Followup,Followup
• Report Date: 10/15/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (ST)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 01/15/2021; 09/01/2021; 10/15/2021
• Supplement Dates FDA Received: 01/11/2021; 02/08/2021; 09/23/2021; 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention