BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3023714 · Received March 27, 2013

    Report

    Report Number
    6000030-2013-00059
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "FAILED." ONE OR TWO DAYS FOLLOWING THE PROCEDURE TO REPAIR THE PUMP, THE PATIENT WENT INTO WITHDRAWAL AND BEGAN CONVULSING. IT WAS STATED THAT THE PHYSICIAN HAD FORGOTTEN TO TURN THE DEVICE BACK ON AFTER THE SURGERY, SO THE PATIENT ENDED UP BEING BROUGHT BACK TO THE OPERATING ROOM TO HAVE IT TURNED ON. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT WOULD HAVE EXCESSIVE BRUISING FOLLOWING A PROCEDURE BY THE SURGEON. HE WOULD BE "BLACK AND BLUE" THROUGHOUT HIS BACK, ABDOMEN, SIDE, AND DOWN TO HIS KNEES. THE DRUG USED IN THIS SYSTEM WAS "SOME KIND OF MORPHINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125201 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R