BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182172 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19930
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8840; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CHANGE IN THERAPY EFFECT. THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT 4 DAYS AGO AND ON 2014 (B)(6) THE PATIENT STARTED TO FEEL "VERY LETHARGIC AND NOT WITH IT." THE SYMPTOMS WORSENED ON THE DAY OF REPORT. THE PATIENT WAS NOT GIVEN ANY ADDITIONAL PAIN MEDICATIONS. THE MANUFACTURE REPRESENTATIVE SAW THE PATIENT AT THE MEDICAL FACILITY. A DYE STUDY WAS DONE ON 2014 (B)(6) TO SEE IF THE CATHETER WAS DISLODGED. THE DYE STUDY SHOWED THE DYE WAS CLEARLY GETTING TO THE INTRATHECAL SPACE. THE REPRESENTATIVE RECEIVED A REPORT FROM THE PAIN OFFICE AND HE FOUND A SLIGHT DISCREPANCY IN THE PRESCRIPTION. THE PATIENT WAS ON "PREMIXED" BACLOFEN 4,000MCG/ML AT 1799 MCG/DAY AND DILAUDID 485MCG/ML AT 218MCG/DAY. THE REPRESENTATIVE NOTED THAT IN THE LAST ORDER PLACED FOR THE MEDICATIONS THE ORDER WAS WRITTEN FOR 425MCG/ML OF DILAUDID. THIS WAS NOT CONSISTENT WITH WHAT THE PATIENT WAS EXPERIENCING. THE PATIENT WAS HAVING SIGNIFICANT SYMPTOMS RELATED TO OVERDOSE. THE PATIENT WAS TABLE AT THE TIME OF REPORT AND THEY HAD CONFIRMED THE CATHETER AND PUMP WERE CONNECTED. THE HEALTHCARE PROVIDER WAS LOOKING TO SEE IF THE PATIENT WAS SUPPLEMENTED, IF SO WHAT WAS SUPPLEMENTED. IT WAS NOTED THAT THE PATIENT HAD A FRACTURED FEMUR AS A RESULT OF THE ACCIDENT. THE THERAPY CHANGE REASON HAD NOT YET BEEN DETERMINED. THE PHYSICIAN PLANNED ON ASPIRATING THE MEDICATIONS FROM THE PUMP AND SEND THEM TO A LAB FOR ANALYSIS. THEY WANTED TO WAIT UNTIL THE PATIENT HAD BEEN DISCHARGED. THE INSTITUTION THAT THE PATIENT HAD BEEN ADMITTED TO WOULD NOT PROVIDE COMPOUND BACLOFEN AND DILAUDID TO BE PUT BACK INTO THE PUMP. THE PATIENT WAS DOING MUCH BETTER AS OF 2014 (B)(6), STILL AN INPATIENT BUT THE LETHARGY WAS LESS. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661784 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization