BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4233813 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21116
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE CATHETER REVEALED A DARK RESIDUE OCCLUSION IN THE DISPENSING HOLES. IT WAS NOTED THAT, AS RECEIVED, THE CATHETER WAS NOT ATTACHED TO THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PUMP REPLACEMENT, A CATHETER OCCLUSION WAS IDENTIFIED, AS THERE WAS NO FLOW FROM THE CATHETER. THE OCCLUSION WAS IN THE DISTAL SEGMENT, AS IT APPEARED CLOGGED. THE CATHETER WAS REPLACED. NO ADDITIONAL ACTIONS OR INTERVENTIONS WERE TAKEN. IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. AS FAR AS THE REPORTER KNEW, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE REPLACEMENT. HOWEVER, THE REPORTER HAD NOT HAD CONTACT WITH THE PATIENT OR DOCTOR SINCE THE REPLACEMENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE CAUSE OF THE EVENT, PATIENT SYMPTOMS, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715871 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR