MAUDE Adverse Event Report: COCHLEAR LTD . NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM; MCM

Model Number CI22M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Shock (2072)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

This report is filed february 5, 2016.

Event Description

Per the clinic, the patient experienced pain and shocking with device use.Subsequently on (b)(6) 2016, the device was explanted and the patient was reimplanted with a new device during the same surgery.

Manufacturer Narrative

This report is filed june 30, 2016.

• Brand Name: NUCLEUS 22 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: 5414223
• MDR Text Key: 37610171
• Report Number: 6000034-2016-00179
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 890027
• 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: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• 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
• Patient Age: 25 YR