MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI24RE(CA)

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 14, 2020.

Event Description

Per the clinic, the patient experienced oedema and infection at the implant site.The device was explanted on (b)(6) 2020.It is unknown if there are plans to re-implant the patient with another device.

Manufacturer Narrative

Correction: the correct date of awareness is may 11, 2020; not april 15, 2020 as previously reported on july 14, 2020.Device analysis report attached.This report is submitted on may 16, 2024.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 10269076
• MDR Text Key: 198678472
• Report Number: 6000034-2020-01888
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)131104(17)151103
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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: 11/03/2015
• Device Model Number: CI24RE(CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2013
• 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): Required Intervention
• Patient Sex: Female