BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172575 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10432
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿COULDN¿T DRIVE BACK AND FORTH¿ TO THEIR HEALTH CARE PROVIDER (HCP) AND THE PUMP RAN OUT OF MEDICATION. THE TIME OF THE EVENT WAS UNKNOWN TO THE REPORTER. IT WAS THEN REPORTED ¿IT HAD HAPPENED A COUPLE TIMES BEFORE BECAUSE I WENT THROUGH THE SAME THINGS. SOMETIMES WE FILL MY PUMP AND THE PUMP WAS EMPTY, NO MEDICATION, ZERO IN THAT PUMP¿. THE PATIENT¿S PRIMARY CARE PHYSICIAN DIDN¿T KNOW WHAT WAS GOING ON ONE OF THE TIMES AND HAD THOUGHT IT WAS A ¿BAD KIDNEY DEAL OR SOMETHING¿. THE PATIENT WAS THEN PUT ON ANTIBIOTICS AND WAS SENT TO A SPECIALIST. THE SPECIALIST THEN TOLD THE PATIENT ¿WE NEED TO PUT YOU IN THE HOSPITAL¿. IT WAS REPORTED, ¿SO I WAS ACROSS THE STREET FROM THE HOSPITAL, THEY CARRIED ME TO THE HOSPITAL RIGHT THEN AND PUT ME IN INTENSIVE CARE UNIT (ICU) FOR A WEEK.¿ IT WAS REPORTED THE PATIENT ¿A COUPLE OF TIMES¿ ENDED BACK OVER AT HIS MANAGING HCP¿S OFFICE IN THE ¿SAME¿ CONDITION. THE HCP WOULD SIT HIM DOWN, GIVE HIM BOLUSES ¿AND WHATEVER THEY DID TO GET ME BACK, KIND OF STABILIZED EVEN WHEN THE PUMP RAN OUT OF MEDICINE¿. IT WAS REPORTED THE PATIENT¿S MANAGING HCP ¿JUST DIDN¿T KNOW HOW TO CHECK THE MEDICATION¿. HOWEVER IT WAS THEN REPORTED THE HCP ¿TURNED ME ON MY SIDE, HE DONE EVERYTHING HE COULD TO SEE IF THERE WAS ANY MEDICATION. HE DID REFILL THE PUMP¿. THE PATIENT REPORTEDLY HAD EXPERIENCED WITHDRAWALS; HE WAS ¿SICKER THAN A DOG¿, WAS SWEATING AND LOOKING ¿LIKE HELL¿. WHEN THE PATIENT HAD WALKED INTO HIS HCP¿S ¿THEY¿RE GOING WHAT¿S RIGHT WRONG WITH YOU? I BELIEVE THEY KNEW WHAT WAS WRONG WITH ME. THE GUY THAT PUT THE PUMP IN CLAIMED HE DIDN¿T KNOW THAT I WAS IN FULL BLOWN WITHDRAWALS.¿ IT WAS NOTED WHEN THE PATIENT KEPT GOING TO HIS HCP¿S, HE WAS FOUND TO NOT HAVE FEVER AND WAS CHECKED FOR INFECTION IN HIS BLOOD, WHICH WAS NEGATIVE. NO FURTHER INFORMATION WAS REPORTED. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM AT THE TIME OF THE REPORTED EVENTS WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273905 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization