BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202112 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00867
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 11, 2012
    Report Date
    April 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET FILL MAY HAVE TAKEN PLACE. DURING A REFILL ON (B)(6) 2012 THE EXPECTED RESERVOIR VOLUME WAS 2.2 ML, BUT 3.0 ML OF DRUG WERE ASPIRATED FROM THE PUMP. THE PUMP HAD NOT BEEN ACCESS IN OVER A YEAR AND SO THE NURSE HAD TO INSERT THE SYRINGE TWO OR THREE TIMES DURING THE REFILL TO ACCESS THE PORT. THE DAY AFTER THE REFILL THE PATIENT HAD SOME SWELLING AND INFLAMMATION OVER THE PUMP SITE. IT WAS UNCLEAR IF THE AREA WAS INFLAMED DUE TO A POCKET FILL OR THE MULTIPLE NEEDLE INSERTIONS. THE RESERVOIR VOLUME WAS GOING TO BE CHECKED TO VERIFY THAT THE DRUG WAS IN THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301835 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other