BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2945659 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01349
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 10, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRIDGE BOLUS HAD BEEN INCORRECTLY PERFORMED. THE PRIMARY DRUG IN THE PUMP WAS HYDROMORPHONE, BUT THE PATIENT WAS ONLY HAVING HIS CONCENTRATION OF CLONIDINE CHANGED. HOWEVER, THE BRIDGE BOLUS WAS PROGRAMMED USING THE OLD DOSAGE OF HYDROMORPHONE, 2.9088MG, INSTEAD OF THE CORRECT DOSAGE, 6.995MG. ABOUT TEN HOURS AFTER THE BRIDGE BOLUS, THE PATIENT BEGAN HAVING INCREASED PAIN. THE THREE DRUGS USED IN THIS SYSTEM WERE HYDROMORPHONE, CLONIDINE, AND BACLOFEN. EIGHTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS DOING "WELL." HE HAD COME BACK INTO THE CLINIC AND HIS PUMP WAS SET TO THE CORRECT DOSE. THE PATIENT'S PAIN RESOLVED AND NO FURTHER PROBLEMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49923 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1