BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3390771 · Received October 7, 2013

    Report

    Report Number
    3004209178-2013-17544
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 17, 2013
    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: 8590-1, LOT# N182450 , IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNDERGOING BACK SURGERY ON (B)(6) 2013, AND THE CATHETER WAS ACCIDENTALLY CUT. THE PUMP SECTION WAS LIGATED DURING THE SURGERY, AND THE SPINAL SECTION OF THE CATHETER WAS REMOVED. THE HEALTHCARE PROVIDER WANTED TO KNOW HOW TO SHUT THE PUMP OFF. THE MEDICATIONS INFUSED WERE CLONIDINE, BACLOFEN, AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507672 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR