BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3961588 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13598
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A FAMILY MEMBER INDICATING THE PATIENT HAD DIED ON (B)(6). THE CAUSE OF DEATH WAS LUNG CANCER. IT WAS REPORTEDLY NOT DEVICE RELATED. WHEN THE PATIENT HAD THE PUMP THEY HAD MORPHINE PUT IN IT. THE PATIENT WAS VOMITING AND THEY WENT TO THE ER THREE TIMES (B)(6). THEY COULD NOT GET A HOLD OF THEIR DOCTOR AND THE PATIENT ENDED UP WITH URINARY RETENTION. THE CATHETER WAS CLOGGED UP AND THEY TOLD THE DOCTOR TO PULL IT, AND THE UROLOGIST DID. THEY TRIED TO IRRIGATE IT AND THEY COULD NOT. THE CATHETER WAS PULLED AND IT SOMEHOW PERFORATED THE BLADDER. THEY WERE TRANSFERRED TO ANOTHER ER ON (B)(6) AND THEY DID A CYSTOGRAM AND INJECTED DYE INTO THE CATHETER. THEY CONFIRMED THE PATIENT HAD CANCER IN THEIR LUNGS, AND THAT THEIR BLADDER WAS NOT PERFORATED. THEY HAD FOUND OUT THE PATIENT¿S LUNG CANCER SPREAD. THE PATIENT HAD 1,650 CC¿S OF FLUID IN THEIR BELLY. THE PATIENT¿S DOCTOR CAME TO THE HOSPITAL AND TURNED THE PUMP DOWN SO THE ¿PUMP WOULD NOT BURN OUT¿. ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATING THE PATIENT HAD BEEN PRESCRIBED A URINARY CATHETER. A MAN OF THEIR AGE WAS EXPECTED TO HAVE URINARY RETENTION AFTER A SURGERY WITH THE USE OF MORPHINE, AND IT WAS NOTED TO BE A NORMAL SIDE EFFECT. THE VOMITING WAS FROM A SECONDARY PNEUMONIA WHICH THE PATIENT HAD DUE TO THEIR ADVANCED END STAGE LUNG CANCER. THE PATIENT DIED WITHIN A MONTH OF HAVING THE PUMP SURGERY, BUT IT WAS NEITHER DEVICE NOR SURGERY RELATED. THE CAUSE OF DEATH WAS FROM THE CANCER AND THE SECONDARY CAUSE WAS PNEUMONIA. THE PATIENT HAD A VERY LOW IMMUNE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439162 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention