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

Model Number CI422

Device Problem Expulsion (2933)

Patient Problem Unspecified Infection (1930)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

This report is filed on july 22, 2019.

Event Description

Per the patient's surgeon, the patient experienced extrusion of the electrode array and infection; subsequently the device was explanted on (b)(6) 2018.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 8810169
• MDR Text Key: 151703139
• Report Number: 6000034-2019-01312
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)171108(17)191107
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 07/08/2019

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: No Information
• Device Expiration Date: 11/07/2019
• Device Model Number: CI422
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR