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

Model Number CI522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Head Injury (1879); Pain (1994); Swelling (2091)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 6, 2020.

Event Description

Per the clinic, the patient experienced pain and swelling at the implant site, subsequent to sustaining a head trauma (specific date not reported).The patient was hospitalised for a duration of three days on (b)(6) 2020, and treated with intravenous antibiotics.The implanted device remains.

• 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, nsw 2109 ; AS 2109
• Manufacturer Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 10371618
• MDR Text Key: 201828970
• Report Number: 6000034-2020-02008
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)180705(17)200704
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 07/16/2020

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: 07/04/2020
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 YR