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

Model Number CI24RE (CA)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/17/2014

Event Type  Injury  

Manufacturer Narrative

This report is filed march 12th, 2015.

Event Description

Per the clinic, the patient was explanted (b)(6) 2014 due to incorrect placement of the device.The device has not been made available for analysis as of the date of this report.

Manufacturer Narrative

(b)(4).The device is currently unavailble.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD.; 14 mars rd; po box 629; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: caleb matthews ; 13059 peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 4394669
• MDR Text Key: 12975204
• Report Number: 6000034-2015-00021
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 7 YR