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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Necrosis Of Flap Tissue (1972); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 5, 2019.

Event Description

Per the clinic, the device was explanted on an unknown date because of an infection and skin necrosis at the implant site.The patient was hospitalized and antibiotics (unknown type) were administered.As of the time of this report, june 5, 2019, it is unknown if the patient has been re-implanted with another device.

Manufacturer Narrative

This report is submitted october 29, 2019.

• Brand Name: NUCLEUS 24 CONTOUR ADVANCE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 8669384
• MDR Text Key: 147016291
• Report Number: 6000034-2019-00932
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)081014(17)101013
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: 10/13/2010
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention