BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3091964 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07242
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED, THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE COULD NOT MAKE COMMUNICATION BETWEEN THE PTM AND THE PUMP. EVERYTIME THE PATIENT PUT IT ON TO WHERE THE PUMP WAS IT KEEPS COMING BACK ON THAT SAYING IT CAN'T FIND HER PUMP. THE PATIENT WOKE UP DURING THE NIGHT AND HER PUMP WAS "STICKING STRAIGHT OUT" AND SHE "PUSHED IT" BACK IN. THE PATIENT STATED THE PUMP "WAS LOOSE IN THERE." THE PATIENT PLANNED TO SEE HER HCP (B)(6) 2013. THE PUMP WAS USED TO DELIVER MORPHINE. THE HCP LATER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN AS THE PATIENT DID NOT CONTACT THEIR OFFICE REGARDING THIS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193762 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1