BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3199468 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11108
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    September 5, 2012
    Report Date
    June 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS TO HAVE HER MEDICATION TITRATED DOWN IN ORDER TO PUT SALINE IN HER PUMP. THE PUMP MAY BE EXPLANTED AS WELL. THE PATIENT WAS CONCERNED AS SHE FELT WAS "IN WITHDRAWAL" AND HAD ISSUES WITH URINATION AND HER BOWELS. REPORTEDLY, THE PUMP WAS ALSO "STICKING OUT" AS IF IT WERE ABOUT TO COME OUT. IT WAS THEN REPORTED THAT THIS PUMP WAS A GREAT BIG ONE AND HURT HER SINCE ITS IMPLANT. THE PATIENT HAD "MORE AND MORE TROUBLE FROM DAY ONE." THE PATIENT TRIED TO HAVE HER DOCTOR CHANGE THE MEDICATION FROM MORPHINE BUT THE PHYSICIAN KEPT PUTTING IN THE SAME MEDICATION. THIS WENT ON FOR A WHILE AND THE PATIENT DECIDED SHE WOULD HAVE THE PUMP TAKEN OUT BECAUSE, SHE WAS "JUST WAGGING THIS BIG THING AROUND AND NOTHING HELPED ME." PATIENT STATED, SHE WAS HAVING "LIFE THREATENING" SYMPTOMS AND "EVERY" SYMPTOM THAT THE MANUFACTURER BOOK NOTED. THE PATIENT'S MEDICATION WAS DOWN TO ABOUT HALF OR LESS AND THE PATIENT HAD TERRIBLE WITHDRAWAL. THE PATIENT HURTS TERRIBLY AROUND THE PUMP. THE PATIENT ASKED HER PHYSICIAN TO ADDRESS THE WITHDRAWAL AND REPORTEDLY THIS WAS NOT DONE. EVENTUALLY, THE PHYSICIAN REPLACED THE MORPHINE WITH DILAUDID. THE DOCTOR TURNED THE PUMP UP AND IT WAS "TOO STRONG" IT WAS TURNED DOWN. THE DOCTOR HAS BEEN TURNING THE DOSE UP AND DOWN A LITTLE AT A TIME APPROXIMATELY 2.5 MONTHS AND THE PATIENT STILL WANTED THE PUMP TAKEN OUT. HER DOCTOR TOLD HER AFTER TURNING THE PUMP DOWN THAT SALINE WOULD REPLACE THE MEDICATION AND THEY FIND SOMEONE TO EXPLANT THE PUMP. THE PATIENT WAS GIVEN A LIST OF DOCTORS IN HER AREA TO CONTACT. APPROXIMATELY NINE MONTHS LATER, THE PATIENT'S PUMP CONTINUED TO HURT HER "VERY BADLY", "STICKING" HER, HURTING IN HER BACK AND "MOVING AROUND, ROLLING ALL OVER MY BODY, AND HANGING HALF WAY FIXED RIGHT OUT." HER PHYSICIAN REPORTEDLY STATED, THE PUMP WAS "MOVING AROUND LIKE A FISH" AND WAS NOT SUTURED "ACROSS ALL AND IN HER STOMACH" AND SHE WAS AFRAID ABOUT THIS. SHE CONTINUED TO REPORT BOWEL ISSUES AND THAT HER KIDNEYS WERE "ON FIRE." THE PATIENT FELT SHE WAS NOT GETTING THE MEDICATION AS SHE WAS IN SO MUCH PAIN. AN APPOINTMENT WAS MADE TO SURGICALLY REPAIR THIS AS REPORTEDLY THE PHYSICIAN DOUBTED IT WAS EVER SUTURED. HOWEVER, THIS REVISION WAS CANCELLED BY THE HEALTH CARE PROVIDER AND ATTEMPTED TO BE RESCHEDULED IN (B)(6) 2013. THIS DEVICE SYSTEM HAD DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297967 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention