BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3022621 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04276
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N172193001, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER: PRODUCT ID 8835. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THERE HAD BEEN RESERVOIR VOLUME DISCREPANCIES AT THE PATIENT'S LAST TWO REFILLS. ABOUT SIX WEEKS PRIOR TO REPORT, THE RESERVOIR CONTAINED 10CC OF DRUG INSTEAD OF THE EXPECTED 2CC. ON THE DAY PRIOR TO REPORT, THE RESERVOIR CONTAINED 7CC OF DRUG INSTEAD OF THE EXPECTED 2CC. THE REPORTER WAS INTENDING TO ASK THE PHYSICIAN TO PERFORM A CATHETER ACCESS PORT (CAP) DYE STUDY AND TRY TO PULL BACK ABOUT 2CC. FIVE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS ONLY GETTING 25% PAIN RELIEF. THE PATIENT'S STATUS HAD NOT CHANGED AT THAT TIME. SIX DAYS AFTER THAT, IT WAS REPORTED THAT THE CAP COULDN'T BE ACCESSED DURING AN ATTEMPTED DYE STUDY. THE DRUG USED IN THIS SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125057 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1