BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3082233 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06992
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED THAT AFTER THE INTERNAL DECONTAMINATION WAS DONE, IT BECAME IMPOSSIBLE TO FILL OR ASPIRATE THE PUMP¿S RESERVOIR, THEREFORE THE PUMPTUBE LEAK TEST AND ANY DISPENSE TESTING COULD NOT BE DONE ON THIS PUMP. THE PUMP, WITH A NEEDLE PUT INTO THE FILLPORT, WAS SUBMERGED UNDER WATER AND 25 PSI OF AIR PRESSURE WAS APPLIED. NO LEAKING WAS SEEN FROM THE SEPTUM. IT WAS ALSO FOUND THAT THE TWO PADS ON THE UPPER BRIDGE AND THE PUMPHEAD COVER WERE NOT IN CONTACT WITH EACH OTHER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A PUMP REVISION IN THE LAST SIX-EIGHT MONTHS. THE PLASTIC SURGEONS PUT A GRAFTING MATERIAL OVER THE PATIENT'S PUMP BECAUSE IT WAS ERODING THROUGH THE SKIN. THE PUMP WAS INFUSING FENTANYL, BUPIVACAINE, AND BACLOFEN.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS EXPLANTED AS IT WAS ¿EXTRUDED¿. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DEVICE WAS RETURNED FOR DISPOSAL ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183618 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention