BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2934135 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01100
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. PURULENT DISCHARGE WAS NOTED FROM THE INCISION SITE OVER THE PUMP POCKET. ON (B)(6) 2010, THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR EVALUATION OF THE PURULENT DISCHARGE. ON THE SAME DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR INTRAVENOUS TREATMENT OF THE INFECTION. THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND TO THE IMPLANT PROCEDURE. THE SEVERITY OF THE EVENT WAS SEVERE AND RESULTED IN IN-PATIENT HOSPITALIZATION. THE PATIENT RECOVERED WITHOUT SEQUELAE ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40916 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R