BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2925006 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00813
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N313191, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS DISCONNECTED BECAUSE OF AN INFECTION, BUT WAS RECONNECTED TWO MONTHS PRIOR TO REPORT. THIRTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD PAIN AND DRAINAGE AT THE INCISION SITE ON (B)(6). IT WAS NOTED THAT A CULTURE OF THE SITE TESTED POSITIVE FOR AN INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND BOTH THE PUMP AND CATHETER WERE REMOVED, THOUGH IT WAS NOTED THAT THE CATHETER REVISION WAS DUE TO PAIN. IT WAS REPORTED THAT THE DEVICE WAS NOT REVISED UNTIL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30993 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention