BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3884531 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11824
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8598, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER; PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PUMP POCKET INFECTION WAS REPORTED. AN ULTRASOUND SHOWED FLUID COLLECTION ON (B)(6) 2013. LAB WORK REVEALED ESCHERICHIA COLI AND KLE BSIELLA PNEUMONIAE ON (B)(6) 2013. THE ENTIRE DEVICE SYSTEM WAS EXPLANTED, AND THE EVENT RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. ETIOLOGY SPECIFIED THE EVENT WAS UNLIKELY RELATED TO THE IMPLANT PROCEDURE, DEVICE, OR THERAPY. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. THE MEDICATION INFUSED WAS GABLOFEN. THE PATIENT HAD A FEVER. PURULENT DRAINAGE WAS ASPIRATED FROM NEAR THE PUMP CATHETER AND SPINAL FUSION HARDWARE. THE PATIENT HAD RECURRENT, CHRONIC OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361375 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R