MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 10, 2019.

Event Description

Per the clinic, the patient experienced infection and abscess (not device related).The device was explanted (b)(6) 2019 and the patient was not reimplanted with a new device.

Event Description

The device was explanted due to infection, performance decrement.The device passed all electrical tests confirming correct device function.

Manufacturer Narrative

This report is filed on february 17, 2020.(b)(4).

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9442837
• MDR Text Key: 170009086
• Report Number: 6000034-2019-02721
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)170119(17)190118
• Combination Product (y/n): N
• PMA/PMN Number: P890027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: Lay User/Patient
• Device Expiration Date: 01/18/2019
• Device Model Number: CI22M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR