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

Model Number CI512

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Deafness (1801)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

The implanted device remains.

Event Description

Per the clinic, imaging performed on (b)(6) 2016 revealed the electrode to be extra cochlear.Subsequently on (b)(6) 2016, the patient underwent revision surgery to reposition the device.The implanted device remains.

• Brand Name: NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
• Type of Device: MCM
• Manufacturer (Section D): COCHLEAR LTD .; 14 mars rd; lane cove, nsw 2066 ; AS 2066
• Manufacturer Contact: angel wright ; 13059 east peakview avenue; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5545433
• MDR Text Key: 41791257
• Report Number: 6000034-2016-00664
• 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
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR