BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120882 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07939
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD NOT RECEIVED PAIN RELIEF FROM THE DEVICE SYSTEM. THE CALLER STATED THAT THE PATIENT HAD EXACTLY THE SAME AMOUNT OF PAIN, IF NOT WORSE, HAS BACK PAIN AND WAS NOW ADDICTED TO THE PAIN MEDICATION. THE CALLER STATED THAT THEY WERE TRYING TO GET THE PATIENT INTO A FACILITY FOR DETOXIFICATION, DRUG REHABILITATION AND PSYCHOLOGICAL COUNSELING RATHER THAN TAKING OPIATES. THE CALLER AND THE PATIENT¿S FAMILY WANTED THE PATIENT WEANED OFF THE MEDICATION IN THE PUMP AND FOR THE PUMP TO EVENTUALLY BE ¿SHUT OFF¿ PRIOR TO BEING ADMITTED TO A FACILITY. THE CALLER HAD SPOKEN TO THE PATIENT¿S HEALTHCARE PROVIDER (HCP) WHO WAS MADE AWARE OF THE DECISION AND WAS FINE WITH IT. THE HCP STATED THAT HE WOULD DECREASE THE PUMP BY 20% AT A TIME; HOWEVER, THE CALLER WANTED THE PUMP DECREASED AT A FASTER RATE. THE PATIENT WAS ALSO TAKING ORAL PAIN MEDICATIONS INCLUDING OXYCODONE, AND WAS CURRENTLY IN THE HOSPITAL AND WAS GIVEN VICODIN. THE CALLER STATED THE DEVICE SYSTEM DELIVERED MORPHINE. IT WAS LATER REPORTED THAT THE HOSPITAL BELIEVED ¿PERHAPS MAYBE SOMETHING WAS GOING ON WITH THE PUMP, WASN¿T WORKING¿. THE PATIENT WAS GIVEN ORAL OPIATES AND MOTRIN AND WAS STILL COMPLAINING OF A LOT OF PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 BUT HAD APPROXIMATELY 6 HOSPITAL STAYS IN THE PREVIOUS MONTH FOR PAIN IN HER CHEST AND SHORTNESS OF BREATH. THE PATIENT HAD BEEN LOOKED AT BY THE HOSPITAL AS WELL AS A CARDIOLOGIST BUT THEY WERE UNABLE TO DETERMINE THE CAUSE. THE PATIENT HAD BEEN GIVEN OXYGEN WHICH RELIEVED HER A LITTLE BIT. THE CALLER HAD JUST TALKED TO THE PATIENT ON THE PHONE AND THE PATIENT WAS CRYING AND IN A LOT OF PAIN. THE CALLER DID NOT BELIEVE THE PATIENT WAS DUE FOR A REFILL. IT WAS LATER REPORTED THAT THE CALLER WANTED THE PUMP TURNED OFF BEFORE (B)(6) 2013 BECAUSE THE PATIENT WAS SCHEDULED TO GO INTO A REHABILITATION FACILITY ON THAT DAY. THE CALLER COULD NOT REACH THE MANAGING PHYSICIAN. THE CALLER STATED THAT THE PRIMARY CARE PHYSICIAN HAD AN ORDER TO TURN THE PUMP OFF AND ¿THAT¿S ALL THEY¿VE GOTTEN¿. THE PHYSICIAN HAD SINCE LEFT THE HOSPITAL. THE PATIENT WAS TO REMAIN IN THE HOSPITAL UNTIL (B)(6) 2013. IT WAS LATER REPORTED THAT ON (B)(6) 2013 THE PATIENT¿S DOSE WAS REDUCED BY 50%. THE CALLER STATED ¿WHAT IS HAPPENING WITH HER IS SHE GOES HOME AND SHE¿S HOME FOR FOUR HOURS AND SHE HAS A PANIC ATTACK AND SHE COMES BACK TO THE HOSPITAL¿. THE CALLER STATED THE PATIENT WAS ¿ON EVERYTHING THAT YOU CAN THINK OF INCLUDING THE MORPHINE PUMP AND IT¿S REDUCING HER BREATHING ABILITY¿. THE PATIENT WAS BECOMING VERY CONFUSED AND ¿IT¿S JUST GETTING REALLY, REALLY, BAD¿. THE CALLER ALSO STATED THAT THE PATIENT WAS PRONE TO SEIZURES SO SHE DID NOT WANT WHATEVER WAS TO BE DONE TO INDUCE A SEIZURE. THE REPORTER LATER PROVIDED CONFLICTING INFORMATION THAT THE DEVICE DELIVERED DILAUDID. THE PATIENT¿S CURRENT DOSE WAS 0.75MG/DAY AND WAS IN THE PROCESS OF BEING WEANED OFF THE MEDICATION. AT THE NEXT REFILL THE CALLER WAS HOPING THEY WOULD JUST FILL THE PUMP WITH SALINE. NO ALLERGIC REACTION WAS FOUND. THE PATIENT WAS DOING BETTER WITH NO CHEST PAIN OR SWELLING. IT WAS LATER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PUMP WAS DECREASED PER THE FAMILY¿S REQUEST. THE PATIENT WAS ADMITTED TO A DETOXIFICATION FACILITY. THE PATIENT WAS TO REMAIN IN THE DETOXIFICATION FACILITY FOR 3 WEEKS AND WHEN SHE WAS DONE SALINE WAS TO BE PUT IN THE PUMP. THERE WAS NO PLAN TO EXPLANT THE PUMP AS THERE WAS ¿NO ISSUE WITH PUMP¿. IT WAS LATER REPORTED THAT THE PUMP OFF CODE WAS REQUESTED AND WAS GIVEN. IT WAS UNCLEAR WHEN THE PUMP WAS TO BE PERMANENTLY TURNED OFF ALTHOUGH THE CALLER HAD RECEIVED CONSENT FROM THE MANAGING PHYSICIAN TO DO SO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LAST MONTH ¿OR SO¿ THE PATIENT DEVELOPED ¿AN ALLERGIC-LIKE REACTION¿. HER HANDS AND FACE HAD ¿SWOLLEN UP¿ AND SHE FELT CHEST PAIN. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ¿FOUR OR FIVE¿ TIMES IN THE PAST MONTH; ¿THREE OF THE TIMES WERE IN ONE WEEK WITH THE SAME SYMPTOMS.¿ THE PATIENT WAS CURRENTLY IN THE HOSPITAL, AT THE TIME OF THIS REPORT. THE PATIENT WAS TOLD SHE MAY BE DEVELOPING AN ALLERGY TO OPIATES. IT WAS NOTED THAT THE PATIENT WAS GETTING BOLUSES VIA HER PUMP, OF DILAUDID EVERY 3.5 HOURS. IT WAS UNCLEAR IF THE PUMP HAD ALWAYS BEEN DELIVERING DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222099 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization