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

Model Number CI422

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is filed, (b)(6) 2016.The implanted device remains.

Event Description

It was reported, the patient fell and sustained trauma near the implant site.The patient has reportedly undergone two surgeries since the incident (dates and surgery details were not reported).The implanted device remains.

• 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: 5692759
• MDR Text Key: 46358077
• Report Number: 6000034-2016-01105
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: 970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention