BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4182239 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19935
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE SCLEROSIS AND WAS HAVING AN MRI TO RULE OUT OSTEOMYELITIS OF HER LEG. IT WAS NOTED THE PATIENT HAD DIFFICULTY COMMUNICATING. DURING THE MRI, THE PATIENT WAS MOANING AND ¿SQUEEZING LITTLE TUBE¿ WHICH PER THE MRI TECHNICIAN WAS NOT ABNORMAL FOR THE PATIENT. THE PATIENT HOWEVER WAS ASKED IF IT WAS BURNING AND THEY SAID YES. THE PATIENT WAS REPORTEDLY AND SUPPOSEDLY EXPERIENCING ¿SOME DISCOMFORT¿ OVER THE PUMP SITE DURING THE MRI. SINCE THE PATIENT WAS NON-VERBAL HOWEVER IT WAS DIFFICULT TO CONFIRM. THE MRI WAS DISCONTINUED. THE PATIENT HAD HAD MANY MRIS IN THE PAST AND THEY WERE GOING TO REVIEW OPTIONS TO SCAN HER AGAIN. THERE WERE NO THERAPY SYMPTOMS OR ISSUES REPORTED AND THE DEVICE MANUFACTURER REPRESENTATIVE HADN¿T HEARD ANYTHING RELATED TO THE PATIENT FOLLOWING THE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661949 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR