BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3830256 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09561
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A ROUTINE PUMP REPLACEMENT, AND ONCE THE HEALTH CARE PROVIDER (HCP) HAD THE OLD PUMP OUT, THEY TRIED TO ASPIRATE THE CATHETER AND WAS GETTING MEDICATION/CEREBROSPINAL FLUID (CSF), AND A LOT OF AIR. THE HCP THEN BELIEVED THERE COULD BE A BREAK IN THE CATHETER. THEN, BY INSPECTION, A HOLE/BREAK WAS FOUND IN THE CATHETER NEAR THE PUMP CONNECTOR PIECE. THIS PIECE WAS CUT OFF AND REPLACED. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT, AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY. THE PUMP WAS BEING USED TO DELIVER BACLOFEN, MORPHINE, PRIALT, HYDROMORPHONE, AND CLONIDINE. IT WAS FURTHER REPORTED THAT THERE WAS NO PRODUCT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307351 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1