BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3951043 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13379
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(6), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP IMPLANTED IN 2004 WAS REPLACED AND THE PATIENT GAINED 100 POUNDS AFTER, SHE WAS FALLING ALL OF THE TIME, COULDN'T WALK, AND THE PUMP CAUSED HER DIVORCE. IT WAS NOTED THAT THE PATIENT HAD A DEFORMED SPINE AND THE PUMP ONLY MADE IT WORSE. IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN SUFFERING SINCE 2004 BECAUSE OF THE PUMP. THE PUMP WAS REMOVED ON (B)(6) 2014. HOWEVER, THE REASON FOR THE PUMP REMOVAL WAS UNCLEAR. PLEASE SEE MANUFACTURER REPORT #S 3004209178-2013-00329 AND 3004209178-2013-00336 FOR ADDITIONAL REPORTED EVENTS. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) COULD NOT ¿SALVAGE¿ THE PUMP OR CATHETER TO RETURN THE MANUFACTURER REPRESENTATIVE FOR ANALYSIS. IT WAS LATER REPORTED THAT THE PATIENT HAD HER STAPLES REMOVED THE WEEK PRIOR TO THIS REPORT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427894 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention