BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202973 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04670
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 11, 2011
    Report Date
    March 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN HCP USING A CLINICIAN PROGRAMMER SAW A MESSAGE ¿INFUSION MODE STOPPED. PUMP STOPPED.¿ DURING A PUMP INTERROGATION. THE HCP THEN REPROGRAMMED THE PUMP SETTINGS TO RESOLVE THE ISSUE. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302930 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR