ASCENDA

Additional Manufacturer Narrative

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: PUMP. (B)(4).

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE (CONCENTRATION AND DOSE UNKNOWN BY THE REPORTER) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. ON (B)(6) 2015, THE PATIENT REPORTED THAT SHE HAD A PUMP REVISION ON (B)(6) 2015. THE PATIENT HAD PAIN; SHE DID NOT REMEMBER WHEN THE PAIN STARTED. THE PUMP WAS NOT IN THE RIGHT SPOT AND HAD TO BE TACKED DOWN. PER THE PATIENT, THE HCP (HEALTHCARE PROFESSIONAL) CLEANED "YELLOW, PUSSY STUFF OFF THE PUMP" AND IT WAS ANCHORED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP ON (B)(6) 2015 AND IT WAS REPORTED THAT THERE WAS NO "YELLOW PUS"; IT WAS FAT CELLS. PER THE HCP, THE PUMP MIGRATED THE SAME AS HER BREAST IMPLANT AND BOTH REQUIRED REVISION. THE CAUSE OF THE PUMP MIGRATION WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER PATIENT. THE EVENT OCCURRED ON (B)(6) 2015. THE PATIENT WAS NOT GETTING PAIN RELIEF AND PAIN WAS AT THE PUMP SITE. THE PUMP SHIFTED DOWN LOWER IN BUTTOCKS AND CATHETER HAD MIGRATED OUT OF INTRATHECAL SPACE. IT WAS UNKNOWN WHAT LED TO THE EVENT. THE PATIENT DID DESCRIBE ISSUES WITH THE "IMPLANTS SHIFTING, PATIENT EXPLAINED A TISSUE DISORDER." A DYE STUDY WAS DONE TO REVEAL DISPLACEMENT OF CATHETER. THE CATHETER WAS REPLACED AND THE POCKET WAS REVISED ON (B)(6) 2015. THE MANUFACTURER REPRESENTATIVE KNEW THAT THE PATIENT WAS EXPLAINED ABOUT ISSUES THAT OCCURRED AND THAT THEY UNDERSTOOD WHAT HAD TO BE DONE. THE PATIENT'S STATUS AT TIME OF REPORT WAS NOTED AS "ALIVE-NO INJURY." THE MANUFACTURER REPRESENTATIVE WAS INFORMED OF THE EVENT ON (B)(6) 2015. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.