MAUDE Adverse Event Report: COCHLEAR LTD. NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM

Model Number CI522

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed on (b)(6) 2016.Implanted device remains.

Event Description

Per the clinic, the electrode array was found to be outside the cochlea; subsequently the patient underwent revision surgery on (b)(6) 2016 to reposition the electrode array.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 6013337
• MDR Text Key: 56914433
• Report Number: 6000034-2016-01966
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)160524(17)180524
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2016
• 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