BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3926426 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12790
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 17, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD, BUT TELEMETRY WAS NOT YET PERFORMED. IT WAS NOTED THE PUMP STARTED ALARMING ON (B)(6) 2014 EVERY HOUR. IT WAS ALSO REPORTED THE PUMP WAS IMPLANTED ALMOST SEVEN YEARS. IT WAS REPORTED THE PATIENT DID NOT HAVE A PHYSICIAN AND THE PATIENT HAD BEEN TRYING FOR 8 MONTHS TO FIND A PHYSICIAN BECAUSE HE WAS DROPPED BY HIS DOCTOR. IT WAS FURTHER REPORTED THE PATIENT¿S PUMP RUNS OUT OF MORPHINE IN TWO WEEKS. THE (B)(6) WAS TRYING TO ASSIST HIM, BUT THEY HAD NOT COME UP WITH A PHYSICIAN OPTION YET FOR THE PATIENT. THE PUMP WAS BEING USED TO DELIVER MORPHINE. ADDITIONAL REPORTED THE PUMP HAD BEEN DRY AND ALARMING FOR ALMOST 2.5-3 WEEKS. IT WAS STATED THE BATTERY WAS GOING TO BE DEAD IN A COUPLE WEEKS. IT WAS NOTED THE PATIENT DID NOT REALLY WANT A REPLACEMENT. IT WAS NOTED THEY WERE WORRIED ABOUT THE ¿FLUID IN THERE¿ AND DID NOT WANT A SPINAL HEADACHE. ADDITIONAL INFORMATION NOTED IT WAS A ¿USELESS PUMP, AND IT WAS A DUD.¿ IT WAS NOTED THE PATIENT WANTED TO GET AN MRI. IT WAS STATED THE PUMP DIDN¿T WORK ANYWAY, SO THEY WANTED TO GET THE MRI. IT WAS NOTED THE PATIENT COULD NOT GET THEIR MRI WITH THE PUMP. ADDITIONAL INFORMATION REPORTED THE PATIENT HAD LUMBAR PAIN. IT WAS NOTED THE PATIENT WAS WAITING FOR APPROVAL FROM THE SURGEONS TO TAKE THE PUMP OUT. IT WAS NOTED THE PUMP WAS ALARMING FOR 3 WEEKS SINCE THE BATTERY WAS DYING AND OVER 2 WEEKS SINCE IT WAS OUT OF MORPHINE. IT WAS NOTED THE PATIENT WANTED A CHANCE AT A BETTER LIFE. PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS REPORTED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403995 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR