BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4191709 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20133
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE - NO LONGER APPLIES TO THIS EVENT.

    Description of Event or Problem · 1

    THE HCP REPORTED SWELLING ALL OVER THE PATIENT¿S BODY BUT IT WAS THE WORST IN THE LEGS. PER THE HCP THE SUDDEN ONSET OF THIS OCCURRED 1 MONTH AGO. THE HCP ORIGINALLY DIAGNOSED IT AS CELLULITIS BUT THEN DETERMINED IT WAS A SIDE AFFECT FROM THE INFUMORPH SO THE DAY OF THE REPORT THERE WAS A DRUG CHANGE TO HYDRO./DILAUDID. THE SYSTEM CONTENT REMOVAL PROCEDURE WAS REVIEWED WITH THE HCP. THE HCP HAD ALREADY TAKEN OUT THE INFUMORPH AND PLACED THE DILAUDID IN THE RESERVOIR WITHOUT DOING A RINSE PRIOR. THE HCP STATED THE PLAN WAS TO PLACE THE PATIENT IN THE HOSPITAL TOMORROW (B)(6) 2014 AND AT THAT TIME WOULD FINISH THE SYSTEM CONTENT REMOVAL PROCEDURE OF THE FINAL PRIME OF THE CATHETER MINUS THE DRUG THAT HAS ALREADY ENTERED IN TO THE CATHETER FROM TODAY UNTIL TOMORROW. ON (B)(6) 2014 THE REPORTER CONFIRMED THE FINAL PRIME OF THE CATHETER TO COMPLETE THE SYSTEM CONTENT REMOVAL PROCEDURE AND WAS ASSISTED WITH THE PROGRAMMING. THE PATIENT WAS REPORTED AS DOING FINE AND IN THE HOSPITAL. THE PUMP WOULD BE PROGRAMMED TO MIN RATE MODE POST PRIME OF THE REMAINDER OF THE CATHETER VOLUME. THE PUMP WAS USED TO DELIVER HYDROMORPHONE.

    Description of Event or Problem · 1

    THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3004209178-2015-05761: IT WAS REPORTED THE PATIENT HAD A REACTION TO THE MORPHINE THAT WAS PUT IN THE PUMP INITIALLY AT DATE OF IMPLANT. THE PATIENT'S LEGS AND FEET WOULD SWELL UP. ON (B)(6) 2014 THE PUMP WAS STOPPED TO SEE IF THE SWELLING WOULD GO AWAY AND IT DID BY (B)(6) 2014. THE PUMP WAS PUT ON MINIMUM FLOW RATE. THE FOLLOWING WEEK MORPHINE WAS TAKEN OUT. ON (B)(6) 2014 HYDROMORPHONE WAS PUT IN THE PUMP. THE PATIENT WAS PUT IN THE HOSPITAL TO BE MONITORED. THE PATIENT HAD A REACTION WITH SWELLING IN LEGS AND FEET AFTER THAT. THE PATIENT WENT TO ANOTHER DOCTOR ON (B)(6) 2014 TO HAVE FENTANYL PUT IN THE PUMP. A RESERVOIR RINSE WAS PERFORMED. THE PUMP WAS FLUSHED WITH SALINE AND REMOVING SYSTEM CONTENTS PROCEDURE WAS PERFORMED. THE PATIENT WAS PUT IN THE HOSPITAL TO ADDRESS THIS AND HE DID NOT HAVE ANY REACTION. ON (B)(6) 2014 THE PUMP MEDICATION WAS INCREASED AND THREE DAYS LATER ON (B)(6) 2014 THE PATIENT'S LEGS AND FEET SWELLED. THE PATIENT INFORMED BOTH DOCTORS RELATED TO HIS CARE ON (B)(6) 2014. THE PUMP WAS PUT ON MINIMUM RATE (B)(6) 2014. THE RESERVOIR DRUG WAS REMOVED BUT PUMP TUBING AND CATHETER WERE NOT CLEARED. THE DOCTOR DISCUSSED PRIALT WITH THE PATIENT ON THAT DATE. THE PATIENT WAS IN TREMENDOUS AMOUNT OF PAIN AND "NOT ONE OUNCE OF RELIEF" HAS BEEN RECEIVED BECAUSE OF ALL THESE EVENTS AND THE PUMP NOT HELPING HIM BECAUSE OF ALL THE SYMPTOMS HE HAS BEEN EXPERIENCING. THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE FENTANYL WASN'T WORKING SO THE HCP STARTED PRIALT (B)(6) 2015. THE PATIENT WAS ALLERGIC TO THE FENTANYL. THE HCP CLEARED THE CATHETER BUT DID NOT PRIME. SALINE WAS PUT IN THE PUMP TO FLUSH IT OUT AND THEN REPEATED THE PROCESS. THE DOCTOR THEN PUT PRIALT IN THE PUMP. THE PATIENT STATED THERE WAS STILL SOME FENTANYL IN THE CATHETER. ON (B)(6). THE PATIENT SPOKE WITH THE DOCTOR AND THE DOCTOR STATED HE WOULD BE BACK ON (B)(6). ON (B)(6) 2015 THE PATIENT WAS "SUPPOSED TO HAVE OLD DRUG FLUSHED OUT". A WEEK PRIOR TO (B)(6) THE PATIENT WAS TOLD THAT THE OLD MEDICATION THAT WAS IN THE PUMP WAS GOING TO BE PULLED OUT OF THE PUMP AND THEN PUT BACK IN. THE PATIENT SAW THE DOCTOR AND HAD TRIGGER POINT INJECTION AND ORAL (PO) MEDICATIONS. THE PATIENT WAS TOLD THAT THE DOCTOR WOULD BE TAKING OUT THE DRUG NEXT WEEK. THE PATIENT INDICATED IT CAN BE DIFFICULT FOR HIM TO TALK. THE REASON FOR THE PUMP IS RELATED TO BURNING PAIN IN HIS LEGS AND A PROSTHETIC JOINT. THE PUMP WAS DELIVERING PRIALT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER (#3004209178-2014-20133).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674126 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization