ASCENDA

Additional Manufacturer Narrative

CONCOMITANT PRODUCT: PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: PUMP. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (CONCENTRATION AND DOSE UNKNOWN) VIA AN IMPLANTED PUMP. THE PATIENT HAD A TRIAL IN 2011 AFTER ORAL BACLOFEN WAS NOT WORKING FOR FAMILIAL SPASTIC PARAPLEGIA (FSP). THE INDICATION FOR PUMP USE WAS INTRACTABLE SPASTICITY AND FAMILIAL SPASTIC PARAPARESIS. THE PATIENT HAD THE PUMP THERAPY FOR SEVERE SPASTICITY. THE PATIENT WAS CURRENTLY HAVING PUMP STUDIES DONE BECAUSE HIS SPASTICITY WAS WORSE. THE PUMP DID NOT SEEM TO BE AS EFFECTIVE AND THE PATIENT WAS "HAVING A LOT OF TROUBLE WITH IT." THE BACLOFEN HAD BEEN INCREASED, "BUT RESULTS HAD NOT BEEN GOOD." ADDITIONAL INFORMATION WAS RECEIVED WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) INDICATED THE PUMP AND CATHETER WERE REPLACED (B)(6) 2016 AND WOULD BE RETURNED. THE PATIENT DESCRIBED A LOSS IN EFFICACY AND HIS SPASTICITY HAD WORSENED RESULTING IN MORE DIFFICULTY AMBULATING. IT WAS UNKNOWN WHAT LED TO THE EVENT AND THE EXACT ISSUE WAS UNKNOWN. THE EVENT DATE WAS UNABLE TO BE OBTAINED. THE HCP DID A ROLLER TEST ON THE PUMP AND HAD QUESTIONABLE RESULTS. THE PHYSICIAN ALSO DID A 50 MCG ITB TEST DOSE VIA LUMBAR PUNCTURE TO PROVE THE PATIENT STILL RESPONDED TO THE MEDICATION. HE HAD A SIGNIFICANT IMPROVEMENT WITH THIS TRIAL. THE PUMP AND CATHETER WERE REPLACED. DURING THE PROCEDURE, MULTIPLE DURAL PUNCTURES RESULTED IN GREAT CEREBROSPINAL FLUID (CSF) FLOW; HOWEVER, THERE WAS NO FLOW OF CSF FROM THE CATHETER. THIS WAS ATTEMPTED MULTIPLE TIMES. THE CATHETER WAS CHECKED FOR FLOW ON THE BACK TABLE BY USING PRESERVATIVE FREE NORMAL SALINE (PFNS) TO FLUSH THE CATHETER TO PROVE THERE WAS NOT A CATHETER OBSTRUCTION. THE SURGEON EVENTUALLY INJECTED DYE AND NOTICED A POCKETING OF DYE. IT WAS REPORTED, "IT DID APPEAR EPIDURAL IN NATURE, BUT THE DYE DID. TO DISPERSE AS EXPECTED EITHER." THE PHYSICIAN SAID THIS COULD BE RELATED TO ARACHNOIDITIS. THE CATHETER WAS PULLED BACK TO THE T10/11 LEVEL AND THERE WAS CSF FREE FLOW FROM THE CATHETER. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE- NO INJURY." IT WAS NOTED THE PATIENT WAS RECEIVING LIORESAL 2000 MCG/ML (DOSE UNKNOWN) AND LOT NUMBER UNABLE TO BE OBTAINED. ADDITIONAL INFORMATION FROM THE COMPANY REPRESENTATIVE INDICATED THE DIAGNOSIS OF ARACHNOIDITIS WAS NOT CONFIRMED. THE MANAGING PHYSICIAN REPORTED THAT THE PATIENT WAS ALREADY SEEING IMPROVEMENT WITH THE NEW PUMP AND CATHETER AT A DAILY RATE OF 100MCG/DAY. THE PATIENT'S MEDICAL HISTORY WAS FAMILIAL SPASTIC PARAPARESIS. OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT WAS UNABLE TO BE OBTAINED. THE LOT NUMBER OF LIORESAL, OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, AND DATE OF DIAGNOSIS OF ARACHNOIDITIS WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

Additional Manufacturer Narrative

THE PREVIOUSLY REPORTED CONCLUSION CODE WAS UPDATED.

Additional Manufacturer Narrative

ANALYSIS OF THE CATHETER FOUND A COMPRESSED AREA WITHIN THE CATHETER BODY AS WELL DAMAGE TO THE TRANSITION TUBING, AND IN REGARDS TO THE PIN CONNECTOR THAT THE COLLET WAS NOT FULLY LOCKED IN PLACE. REFER TO MANUFACTURER REPORT # 3004209178-2015-24833 FOR THE ASSOCIATED PUMP ANALYSIS INFORMATION. UPON RETURN, THE DEVICE WAS INTERROGATED AND REVEALED THE PUMP HAD LAST BEEN PROGRAMMED TO DELIVER FLEX DOSING AT A DAILY DOSE OF 495.1 MCG PER DAY.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.