MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Staphylococcus Aureus (2058)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 13, 2020.

Event Description

Per the clinic, the patient experienced a staphylococcus aureus infection at the implant site, and was hospitalised on (b)(6) 2020 for a duration of 7 days, and treated with iv antibiotics.The patient underwent revision surgery on (b)(6) 2020 for wound cleaning, and a second revision surgery on (b)(6) 2020, for a hematoma drainage and wound cleaning.The patient was hospitalised on (b)(6) 2020, for a duration of 7 days, and treated with iv antibiotics; however the issue could not be resolved, and the device was explanted on (b)(6) 2020.The patient has not been reimplanted with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on 25 september 2020.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM 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: 10399789
• MDR Text Key: 202687831
• Report Number: 6000034-2020-02106
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)200115(17)220114
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2022
• Device Model Number: CI622
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 MO