BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3173680 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10461
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM) WAS DISPLAYING AN INCORRECT REFILL DATE. THE PATIENT HAD A PUMP REFILL ON (B)(6) 2013, AND THE NEXT REFILL HAD BEEN SCHEDULED FOR (B)(6) 2013, BUT THE PTM DATE HAD NOT UPDATED. THE REPORTER DID NOT PROVIDE WHAT DATE WAS DISPLAYED. THE PATIENT WAS PLANNING TO CONTACT THE HEALTHCARE PROVIDER (HCP) TO INQUIRE ON GETTING THE PTM UNCOUPLED AND RECOUPLED PRIOR TO THE REFILL APPOINTMENT, TO UPDATE THE REFILL DATE ON THE PTM. THE PUMP WAS USED TO DELIVER DILAUDID, FENTANYL, BACLOFEN AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT A VAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274646 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR