MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 23, 2019.

Event Description

Per the clinic, the patient experienced a cholesteatoma which resulted in a migration of the electrode out of the cochlea by 1cm.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted 11 february 2020.

• Brand Name: NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9514255
• MDR Text Key: 173911265
• Report Number: 6000034-2019-02886
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)150512(17)170511
• 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
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2017
• Device Model Number: CI522
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR