BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3170330 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10392
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 21, 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
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8583, LOT # N336199, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2013 - ((B)(4)/ENLASO/HCP): IT WAS REPORTED THE PUMP CHANGED POSITIONS, PROTRUDED THROUGH THE PATIENT¿S SKIN, AND CAUSED PAIN. THE REPORTER INDICATED THE PATIENT HAD DIFFICULTY FINDING A PROVIDER TO REFILL THE PUMP. THE PUMP WAS DELIVERING DILAUDID. THE HEALTH CARE PROVIDER (HCP) TITRATED THE PATIENT'S PUMP DOWN, AS THE PATIENT WAS TRAVELING OUT OF STATE AND WAS HAVING DIFFICULTY FINDING A HCP TO MANAGE, REFILL OR TROUBLESHOOT THE PUMP BY CHECKING VOLUMES. IT WAS BELIEVED THE PATIENT HAD APPROXIMATELY TEN DAYS LEFT OF MEDICATION IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271763 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR