BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3073529 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06790
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 28, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD GRADUALLY MOVED DOWNWARD 3 INCHES FROM THE ORIGINAL IMPLANT SITE AND WAS "PULLING" IN HER SIDE. THE PATIENT CURRENTLY HAD SWELLING OVER THE PUMP POCKET SITE THAT WAS FIRST NOTICED 4 WEEKS PRIOR TO THE REPORT. THE PATIENT REPORTED BEING SORE AND TENDER "ALL UP AND DOWN WHERE IT MOVED." THE PATIENT ALSO FELT PAIN IN HER BACK WHERE THE CATHETER WAS PLACED WHEN THE PUMP LAST MOVED. THE PATIENT WAS HITTING THE PUMP ALL OF THE TIME AND IT WAS VERY PAINFUL ON THE WHOLE LEFT SIDE OF HER BODY. THE PATIENT WAS TO SEE HER DOCTOR WITHIN A MONTH WHO MENTIONED POSSIBLY IMPLANTING THE PUMP IN A MESH POUCH. THE PATIENT STATED "I'VE REALLY HAD A PROBLEM WITH THIS EVER SINCE THEY PUT IT IN." THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173348 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1