MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI422

Device Problem Migration (4003)

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

Event Date 09/29/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a migration of the electrode array, resulting in no sound perception.Explant and reimplantation is planned but has not taken place at the time of this report.

Manufacturer Narrative

Per the clinic the device was explanted on (b)(6) 2020.The patient was re-implanted with a new device during the same surgery.This report is submitted on november 9, 2020.

Event Description

Per the clinic the device was explanted on (b)(6) 2020.The patient was re-implanted with a new device during the same surgery.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT 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: 10539002
• MDR Text Key: 207097468
• Report Number: 6000034-2020-02630
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)140822(17)160821
• 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: 11/09/2020,10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2016
• Device Model Number: CI422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2010
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2020
• Distributor Facility Aware Date: 10/16/2020
• Date Report to Manufacturer: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR