MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI632 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM, PRODUCT CODE:

Model Number CI632

Device Problem Migration (4003)

Patient Problem Deafness (1801)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 18, 2019.

Event Description

Per the clinic, the patient experienced no response on activation.The device was explanted (b)(6) 2019 and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

It was reported that the patient's device had extruded prior to explant.This report is submitted 8 january 2020.

Manufacturer Narrative

This report is filed on february 20, 2020.

Event Description

The device was explanted due to misplaced electrode array and non-auditory percepts.The device passed all electrical tests confirming correct device function.

• Brand Name: NUCLEUS CI632 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 22 COCHLEAR IMPLANT SYSTEM, PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9485432
• MDR Text Key: 173902613
• Report Number: 6000034-2019-02838
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)190905(17)210904
• 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
• Report Date: 12/18/2019,01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2021
• Device Model Number: CI632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2019
• Date Report to Manufacturer: 11/25/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR