BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201464 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00010
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8703W LOT# L70871, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DRUG LIORESAL FOR THE IMPLANTABLE INFUSION PUMP WAS NOT AVAILABLE BY THE PATIENT¿S LOW RESERVOIR ALARM DATE, WHICH WAS THE DATE OF THIS REPORT. IT WAS BELIEVED THAT THE EMPTY RESERVOIR ALARM DATE WAS IN TWO DAYS. IT WAS NOTED THAT THE DRUG WAS BEING ORDERED THOUGH A ¿SPECIAL PHARMACY.¿ IT WAS UNKNOWN WHETHER THE DRUG WAS COMPOUNDED. THE PATIENT HAD ORAL MEDICATION, BUT IT WAS UNCERTAIN HOW TO ADMINISTER IT. ADDITIONAL INFORMATION STATED THAT THE PATIENT DID GET A REFILL ON (B)(6) 2012. THE PATIENT DID NOT HAVE ANY SYMPTOMS AS A RESULT OF THE TARDINESS. THE PATIENT WAS ¿GOOD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301684 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR