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

Model Number CI24RE (CA)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  Injury  

Manufacturer Narrative

This report is filed january 28, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced facial nerve stimulation with device use.A ct scan revealed the device to be in the vestibule, resulting in the decision to explant the device.The implanted device remains at this time.However, explant and reimplantation is planned but has not taken place at the time of this report, january 28, 2016.

Manufacturer Narrative

Correction: the correct serial number of the device is (b)(4); not (b)(4) as previously reported.Per the clinic, the device was explanted on (b)(6) 2016; during the same surgery the patient was re-implanted with a new device.This report is filed july 14, 2016.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
• Type of Device: MCM: PRODUCT CODE:
• Manufacturer (Section D): COCHLEAR LTD .; 14 mars rd; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: nicole hille ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5396952
• MDR Text Key: 37037734
• Report Number: 6000034-2016-00139
• 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: Audiologist
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• 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