BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170962 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10412
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 20, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR A MONTH DUE TO ¿HEART ISSUES¿. THE SPECIFIC ISSUES AND WHETHER THE ISSUES WERE RELATED TO THE PUMP OR DRUG WERE NOT REPORTED. THE PATIENT DID NOT SHOW UP FOR HIS REFILL APPOINTMENT IN MAY. IT WAS REPORTED BY ANOTHER SOURCE THAT, AS OF (B)(6) 2013, THE PUMP WAS EMPTY. THE PATIENT HAD GONE IN FOR A REFILL ON THE PRIOR WEDNESDAY, WHEN THE PUMP WAS SUPPOSED TO RUN OUT. IT WAS STATED THAT THE PHYSICIAN HAD NOT ORDERED THE DRUG UNTIL THE PATIENT ARRIVED, SO HE WOULD HAVE NEEDED TO WAIT FIVE HOURS. THE PATIENT CHOSE NOT TO WAIT FOR THE REFILL, BUT THE PHYSICIAN WOULD NOT BE ABLE TO REFILL FOR AT LEAST ANOTHER TWO WEEKS BECAUSE SHE WAS LEAVING ON VACATION. IT WAS STATED THAT THE PATIENT ¿WENT CRAZY¿ DURING THE FIRST FEW DAYS AFTER THE PUMP WENT DRY. AT THE TIME OF THIS REPORT, THE REPORTER WAS LOOKING FOR A PHYSICIAN TO FILL THE PATIENT¿S PUMP. IT WAS REPORTED THAT THE PUMP WAS GOING TO BE FILLED WITH DILAUDID. WHEN THE PATIENT HAD HIS PUMP REFILLED ON (B)(6) 2013, HE WAS FOUR WEEKS OVERDUE FOR A REFILL. THE PATIENT RETURNED TO THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013. THE DEVICE WAS INTERROGATED AND REPROGRAMMED AND THE PATIENT WAS DOING FINE. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT BEEN ON FENTANYL SINCE (B)(6) 2012. AT THE TIME OF THE REPORT, THE PATIENT WAS ON DILAUDID AT 0.9489MG/DAY, 2MG/ML. THE HEALTHCARE PROVIDER (HCP) WAS IN THE HOSPITAL DUE TO CARDIAC ISSUES THAT WERE COMPLETELY UNRELATED TO THE PUMP. IT WAS NOTED THAT THE PATIENT WAS OVERWEIGHT AND A HEAVY SMOKER. THE PUMP WENT EMPTY IN MAY BECAUSE THE PATIENT WAS IN THE HOSPITAL AND MISSED HIS APPOINTMENT ON (B)(6). THE PATIENT HAD TO WAIT UNTIL AFTER BEING DISCHARGED TO GET THE PUMP FILLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CONGESTIVE HEART FAILURE THAT REQUIRED OPEN HEART SURGERY. IT WAS STATED THAT THE SURGERY TOOK PLACE ABOUT FOUR WEEKS PRIOR TO REPORT. THE PATIENT HAD GONE HOME A COUPLE OF TIMES, BUT WAS IN THE HOSPITAL BECAUSE HE HADN¿T BEEN DOING WELL. IT WAS STATED THAT HE WASN¿T HANDLING THE REPLACED BUTTERFLY VALVE TOO WELL. IT WAS ALSO NOTED THAT HIS FEET WERE ¿AS BIG AS BASEBALLS¿ AND HIS BODY WAS BLUE ALL OVER. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, BUT HAD PREVIOUSLY CONTAINED FENTANYL. THE REPORTER DIDN¿T KNOW THAT THE FENTANYL WASN¿T THE CAUSE OF THE HEART FAILURE, AS HE HAD PREVIOUSLY HAD A BAD REACTION TO IT. IT WAS STATED THAT CAUSE OF THE HEART FAILURE WAS UNKNOWN, BUT SOMETHING HAD BEEN TAKEN OUT OF THE ARTERIES FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271057 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R