BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3733923 · Received April 8, 2014

    Report

    Report Number
    3004209178-2014-05787
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    January 1, 2008
    Report Date
    March 18, 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 MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# J0039925R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# N123021, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PUMP WAS IMPLANTED, IT WAS IMPLANTED IN THE PATIENT¿S RIGHT SIDE AND IT WAS ¿TOO HIGH.¿ WHEN THE PATIENT WOULD BEND OVER THE PUMP WOULD HURT HER RIB CAGE. THE PATIENT STATED THAT THE PUMP WAS LOWERED IN (B)(6) 2008. THE PATIENT STATED ¿WHEN IT GOT LOWERED I HAVE THIS BIG BULGE IN MY STOMACH AND EVERYONE SAYS IT¿S EITHER A TEAR OR HERNIA THEY¿RE NOT SURE.¿ THE PATIENT STATED THAT SHE HAD LOST AND GAINED WEIGHT OVER THAT PERIOD OF TIME. THE DEVICE SYSTEM DELIVERED FENTANYL AND DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210535 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention