BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3260004 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-12640
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD CONCERNS REGARDING ¿RESTRICTIONS¿ FROM INSURANCE COMPANIES, THE GOVERNMENT ETC., REGARDING THE QUANTITY OF MEDICATION USED AT REFILLS, I.E., ONLY ALLOWING 20ML CAN BE FILLED AT ONE TIME (EVEN IF A 40ML PUMP). THE PATIENT WAS ABOUT TO DECIDE WHEN THE BATTERY NEEDED TO BE REPLACED IN THE NEXT FEW MONTHS TO NOT HAVE THE PUMP REPLACED BUT JUST HAVE IT REMOVED AS THE PAIN PUMP HAD ¿TOO MANY ISSUES¿ ASSOCIATED WITH IT AND THE PATIENT COULDN¿T TRUST THE PAIN PUMP WOULD BE FORCED TO BE DISCONTINUED DUE TO ALL THE ¿PROBLEMS¿, WHICH THE PATIENT FELT INCLUDED THE LACK OF HCP WHO WILL TREAT PAIN PUMP PATIENT¿S DUE TO LOSS OF REVENUE OR NOT BEING REIMBURSED FOR THE COST OF MEDICATION WHICH THE PATIENT HAD BEEN FIGHTING TO KEEP HIS PAIN PUMP. THE PUMP WAS USED TO DELIVER FENTANYL AND BUPIVACAINE

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS HCP OR MANUFACTURE REPRESENTATIVE. IT WAS ALSO NOTED THE PATIENT HAS NOT SOUGHT FURTHER HELP. THE PATIENT CONTINUED TO HAVE CONCERNS REGARDING REIMBURSEMENT AND REFILLS ETC.. THE PATIENT ALSO HAD AN APPOINTMENT 8/21/13 FOR A REFILL WITH THE TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360404 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR