BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3111352 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07615
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, LOT # N176223011, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD STOPPED WHEN THEY WERE UPDATING IT. THE REPORTER CONFIRMED THAT THEY THOUGHT IT WAS AN INTERRUPTION IN THE TELEMETRY "OR SOME KIND OF INCIDENT." THE HEALTHCARE PROVIDER FURTHER STATED THAT THEY WERE UPDATING THE PUMP BECAUSE THEY HAD TO INCREASE IT. THEY WERE INCREASING IT BECAUSE, WHEN THE PATIENT CAME IN LAST MONTH, THEY HAD DECREASED IT INSTEAD OF INCREASING. THE PATIENT CAME IN SO THEY HAD TO "FIX IT." NO SYMPTOMS WERE REPORTED. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, BUPIVACAINE, AND CLONIDINE. IT WAS LATER REPORTED THAT IT WAS A DOSAGE PROGRAMMING ERROR, AND NOT A CONCENTRATION PROGRAMMING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213101 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR