BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2160943 · Received June 16, 2011

    Report

    Report Number
    6000030-2011-04530
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    RICK CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS LAST PROGRAMMED ON (B)(6) 2011 AT 13:52 WITH A DOSE OF 1.388 MG/DAY. ON (B)(6) 2011, THE PROGRAMMING SAID LAST CHANGE WAS ON (B)(6) 2011 AT 14:00 WITH A DOSE OF 1.323MG/DAY. THE PUMP HAD ONLY BEEN UPDATE ONE TIME. IT WAS NOTED THAT THE PUMP WAS BEING TITRATED BECAUSE THE PT WANTED IT REMOVED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICK CREEK MANUFACTURING 8627L10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR CATHETER: MODEL 8709, LOT# J11376R48| IMPLANTED:| EXPLANTED: