MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI532

Device Problem Migration (4003)

Patient Problems Hearing Impairment (1881); Unspecified Infection (1930)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 10 janurary 2020.

Event Description

Per the patient's surgeon, the device was explanted on (b)(6) 2019 due to infection, electrode migration and poor performance with device use.There are no plans to re-implant the patient with a new device as of the date of this report.

Event Description

It was reported that the patient experienced extrusion of the device prior to explantation, the infection was treated with oral and topical antibiotics.

Manufacturer Narrative

This report is submitted on 24 march 2020.

• Brand Name: NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9572134
• MDR Text Key: 174476384
• Report Number: 6000034-2020-00198
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)181029(17)201028
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/24/2020,02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Distributor Facility Aware Date: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR