BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3191411 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10942
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8835, LOT # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8840, LOT # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) LATER CONFIRMED THAT THE CAUSE OF THE EVENT WAS THE PHYSICIAN DID NOT UPDATE THE VOLUME, AND THE PATIENT LEFT TOWN IMMEDIATELY AFTER THE VISIT. THERE WAS NO ADVERSE EVENT OTHER THAN CONSTANT BEEPING. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, AND THEIR OUTCOME WAS NO INJURY. THE PATIENT¿S NEXT REFILL WAS ON (B)(6) 2013. THE HEALTHCARE PROVIDER LATER REPORTED THAT THE PATIENT SHOWED UP AT THE CLINIC ON (B)(6) 2013 AND THEY WANTED THEIR PUMP REFILLED. THEIR HCP WAS DECIDING IF THEY WOULD REFILL IT (AS THEY DID NOT HAVE THE COCKTAIL OF DRUG READILY AVAILABLE) OR IF THEY WOULD FILL IT PRESERVATIVE FREE NORMAL SALINE, PROGRAM IT TO MINIMUM RATE MODE, WAIT UNTIL THE DRUG WAS AVAILABLE TO PERFORM THE REFILL, AND SUPPLEMENT THE PATIENT WITH ANOTHER FORM OF PAIN MEDICATION. THE PATIENT WAS NOT IN WITHDRAWAL. ACCORDING TO THE LOGS, THE LOW RESERVOIR ALARM DATE WAS (B)(6) 2013. THE PATIENT STATED THEIR PTM PROGRAMMER HAD NOT BEEN WORKING, AND THE LAST PTM REQUEST WAS NOTED TO HAVE OCCURRED ON (B)(6) 2013. AN ERRONEOUS LOW RESERVOIR ALARM OCCURRED AT 18:46 ON THE SAME DATE AS THE LAST PUMP REFILL ON (B)(6) 2013 AT 15:17.

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT A PATIENT REALIZED THEIR PUMP WAS BEEPING SINCE THREE WEEKS PRIOR TO THE REPORT. THE PATIENT¿S REFILL WAS NOTED TO HAVE OCCURRED AROUND THE SAME TIME AS WHEN THE ALARM STARTED. THE REPRESENTATIVE REPORTED THAT THE HEALTHCARE PROVIDER READ THE PUMP STRIP, AND ¿THEY DID NOT UPDATE THE RESERVOIR VOLUME AFTER THE REFILL.¿ THE PATIENT WAS NOT HAVING WITHDRAWAL SYMPTOMS. THE PATIENT¿S HEALTHCARE PROVIDER HAD CALLED THE REPRESENTATIVE AND NOTED THE PATIENT¿S PUMP WAS BEEPING AND THEY WERE NOT SUPPOSED TO BE REFILLED UNTIL (B)(6) 2013. THE REPRESENTATIVE NOTED THE PATIENT WAS NOT ABLE TO GIVE THEMSELVES A BOLUS; THAT THEIR REFILL DATE ON THE PTM SAID ¿MAY SOMETHING,¿ AND IT KEPT COMING UP WITH THE ¿BELL AND A DOCTOR PICTURE¿. THE PATIENT REQUESTED A REPRESENTATIVE COME TO SILENCE THEIR ALARM. THE PATIENT STATED THAT THEIR PHYSICIAN LOWERED THE AMOUNT OF DRUG THEY WERE GETTING SO THAT IT WOULD ¿LAST A LITTLE LONGER¿. THE PATIENT¿S PRIMARY PHYSICIAN WAS IN CALIFORNIA AND THE PATIENT WAS IN OREGON. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, CLONIDINE, BUPIVACAINE, AND BACLOFEN. THE PATIENT REPORTED THEIR LAST REFILL SESSION WAS ON ABOUT (B)(6) 2013. A REPRESENTATIVE LATER REPORTED THAT THE PATIENT HAD NOT YET FOUND A REPRESENTATIVE IN OREGON TO UPDATE THEIR PUMP. A REPRESENTATIVE LATER CONFIRMED THE PATIENT¿S REFILL HAD BEEN PERFORMED ON (B)(6) 2013. THEY ALSO STATED THAT THE HEALTHCARE PROVIDER UPDATED THE PUMP, BUT THEY DID NOT CHANGE THE RESERVOIR VOLUME TO READ 20. THEY STATED THAT THE PUMP ¿THOUGHT IT WAS EMPTY, BUT IT REALLY WAS NOT.¿ THE PATIENT STILL DID NOT HAVE ANY SYMPTOMS. THE PATIENT LATER REPORTED THEIR ALARM WAS BEEPING EVERY FIFTEEN MINUTES. THE PATIENT WAS STILL LOOKING FOR A HEALTHCARE PROVIDER AND REPRESENTATIVE TO UPDATE THEIR PUMP. ANOTHER REPRESENTATIVE LATER REPORTED THAT THE PATIENT LEFT A MESSAGE AND LET THEM KNOW WHERE THEY WERE RESIDING. THE PATIENT WANTED TO MEET A REPRESENTATIVE IN THE TRI-CITIES WASHINGTON AS THAT WAS THE CLOSEST ¿BIG CITY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291513 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR