BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2954992 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02503
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROGRAMMER: MODEL: 8835, SERIAL# (B)(4). CATHETER: MODEL: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A "WOUND DEVELOPING AT LOWER EDGE OF PUMP SITE RESEMBLING POSSIBLE (B)(4) VS. PRESSURE ULCER". THEY WERE UNABLE TO ASPIRATE FLUID AT THE POCKET SITE. INTERVENTIONS HAVE INCLUDED: MEDICATION ADJUSTMENT, SPECIFIC MEDICATION, DOES, AND ROUTE OF ADMINISTRATION. THE PATIENT WAS BEING INFUSED WITH MORPHINE AND BUPIVACAINE VIA THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT HAD A DECUBITUS ULCER ON THE RIGHT BUTTOCKS, NEAR THE PUMP POCKET. IT WAS DETERMINED THERE WAS NOT AN INFECTION BUT AN ULCER, POSSIBLY RELATED TO EXCESS PRESSURE FROM THE PUMP. THE MEDICATION WAS ADJUSTED; AUGMENTIN. THE DEVICE WAS SURGICALLY REPOSITIONED BY MOVING THE PUMP POCKET, ON (B)(6) 2013. A CULTURE OF THE WOUND WAS ALSO DONE. THE RESULTS WERE REPORTED AS "POSITIVE RBC'S, NO ORGANISMS SEEN, NO PMNS AND NO GROWTH."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59782 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention