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

Model Number CI24RE (CA)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fistula (1862); Foreign Body Reaction (1868); Inflammation (1932); Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 26, 2017.

Event Description

Per the patient's surgeon, it was reported that the patient developed a fistula formation with swelling, purulent discharge and a small area of subcutaneous necrotic tissue at the implant site.Cultures taken returned a reading of staphylococcus; however, treatment with antibiotics was unsuccessful.Subsequently, revision surgery was performed in order to resect the necrotic area, and reconstruct the resected area with a rotational flap.It was noted by the surgeon that tissue was present around the receiver stimulator.A pathological exam revealed a giant cell foreign body inflammatory reaction (date of revision surgery not reported).The implanted device remains insitu.

• Brand Name: NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6892921
• MDR Text Key: 87290923
• Report Number: 6000034-2017-01755
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)140228(17)160227
• 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
• Report Date: 09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2016
• Device Model Number: CI24RE (CA)
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2017
• Date Device Manufactured: 02/28/2014
• 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