BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3221752 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-06336
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    August 4, 2010
    Report Date
    April 15, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID : 8709SC SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LOST AROUND 300 POUNDS AND THE PUMP WAS PROTRUDING 6 INCHES OUT OF THE BODY. THE PUMP WAS JAMMED BETWEEN THE RIBS AND THE PELVIC BONE, WHICH WAS CAUSING INTERNAL BRUISING. IT WAS NOTED THAT BIG BRUISES HAD BUILT UP ALL THE WAY AROUND THE PUMP. THE HEALTH CARE PROFESSIONAL HAD REMOVED 4 60CC VIALS OF YELLOW ¿POISONOUS¿ FLUID FROM THE POCKET OF WHERE THE PUMP WAS. IT WAS NOTED THAT THE MEDICINE WAS BECOMING ¿TOXIC¿ IN THE PATIENT¿S SYSTEM, BUT THE DOSE WAS NOT LOWERED. IT WAS REPORTED THAT THE PATIENT BEEN IN SOME SERIOUS ACCIDENTS AND HAD A COUPLE OF STROKES AND MAGNETIC RESONANCE IMAGING SCANS WERE NEEDED. AFTER THE PATIENT¿S CAR ACCIDENT, SALINE WAS PUT IN THE PUMP. IT WAS NOTED THAT THE SYSTEM WAS NOT BEING REMOVED BECAUSE THE CATHETER WAS LOCATED ¿AT THE BASE OF THE BRAIN STEM.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321512 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Other