BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4152918 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18517
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT AND UPON ATTEMPTING TO DISCONNECT THE CATHETER FROM THE PUMP THE CATHETER HUB PULLED AWAY FROM THE PUMP CONNECTOR LEAVING A PORTION OF THE CATHETER ATTACHED TO THE EXPLANTED PUMP. AN 8731SC PUMP SECTION WAS UTILIZED TO REPLACE THE CATHETER PUMP SECTION HUB. THERE WERE NO PATIENT SYMPTOMS REPORTED RELATED TO THE EVENT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER HYDROMORPHONE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632035 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR