BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2183697 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05232
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHARMACIST MIXED 224 MG OF FLOXURIDINE IN 40 CCS OF SALINE AND DEXAMETHASONE. PREVIOUSLY THE CONCENTRATION WAS SET AT 100 MG/ML AND THE DOSE WAS NOT EFFECTIVE WITH LABORATORY RESULTS. THE PATIENT WAS ONLY GETTING .1 CCS OF FLUID EACH DAY WITH THE PREVIOUS FLOW RATE WHEN THE PATIENT WAS TO GET MORE FLUID AND MORE DOSE BY CHANGING THE CONCENTRATION IN THE PROGRAMMER TO THE CORRECT CONCENTRATION. THE PATIENT WAS RECEIVING 14 DAYS OF FLOXURIDINE AND THEN 14 DAYS OF SALINE. ON (B)(6) 2011, IT WAS REPORTED THAT "THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS AS A RESULT OF THE CALCULATIONS. IT WAS A WORK IN PROGRESS TO GET THE DOSAGE CORRECT FOR THE PATIENT, IT WAS BELIEVED THAT HE WAS RECEIVING EFFECTIVE THERAPY". TWO DAYS LATER A VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THERE WAS NO HISTORY OF MRI, FALLS, OR TRAUMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR CATHETER: MODEL 8709SC, LOT #N280253007| IMPLANT DATE: