ASCENDA

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN 2000MCG/ML AT 1100MCG/DAY VIA AN IMPLANTED PUMP. INDICATION FOR USE WAS NOTED AS INTRACTABLE SPASTICITY AND SPINAL CORD INJURY/SPINAL CORD DISEASE. IT WAS REPORTED THAT THERE WAS A CATHETER FAILURE. THE PATIENT'S FAMILY REPORTED AN INCREASE IN THE PATIENT'S SPASTICITY. THE HCP TRIED TO ASPIRATE THE SIDE PORT BUT GOT NO FLOW. A CATHETER REVISION OCCURRED ON (B)(6) 2015. DURING THE CATHETER REVISION, IT WAS DISCOVERED THAT THE CATHETER WAS COMPLETELY BROKEN IN TWO NEAR THE SPINAL INCISION SITE. THE CATHETER WAS FULLY EXPLANTED AND A NEW CATHETER WAS IMPLANTED. THE ISSUE RESOLVED AT THE TIME OF REPORT ((B)(6) 2016). PATIENT'S STATUS AT THE TIME OF REPORT WAS "ALIVE- NO INJURY." THE EVENT DATE, CAUSE OF THE CATHETER BREAK AND DIAGNOSTIC TESTS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.