BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3833489 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09643
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; 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 AT A PREVIOUS REFILL ON (B)(6) 2014, THE ACTUAL RESERVOIR VOLUME (ARV) WAS 10.2ML AND THE EXPECTED RESERVOIR VOLUME (ERV) WAS 5.8ML. PRIOR TO THAT, DISCREPANCIES HAD BEEN AT 1ML, SO THEY DECIDED TO ¿KEEP AN EYE¿ ON THE PUMP. AT THE REFILL ON THE REPORT DATE, A 5ML DISCREPANCY OCCURRED. SPECIFIC VALUES WERE NOT PROVIDED. NO PATIENT SYMPTOMS WERE REPORTED, HOWEVER THE REPORTER HAD NOT YET SEEN THE PATIENT. A DYE STUDY AND ROTOR STUDY WERE TO BE DONE BECAUSE THE VOLUME DISCREPANCIES HAD BEEN INCREASING. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. THE VOLUME DISCREPANCIES BEGAN IN (B)(6) 2014, ALTHOUGH THEY WERE NOT REPORTED UNTIL THIS TIME. THE CAUSE OF THE DISCREPANCIES WAS PRESUMED BE HUMAN ERROR ON PART OF THE REFILL NURSE. CATHETER DYE AND ROTOR STUDIES WERE NORMAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310034 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR