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

Model Number CI24R (CS)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 15, 2018 (b)(4).

Event Description

Per the surgeon, it was reported that the patient experienced skin flap breakdown, drainage at the implant site and extrusion of the implant.Subsequently, the surgeon recommended wound care and prescribed antibiotics (type not reported).The implanted device remains and the patient is being clinically managed by the health care provider.

• Brand Name: NUCLEUS 24 CONTOUR
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7783926
• MDR Text Key: 117125146
• Report Number: 6000034-2018-01715
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24R (CS)
• Date Manufacturer Received: 08/09/2018
• 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): Required Intervention