BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3012569 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03955
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE PUMP POCKET SITE AND THE PUMP AND THE CATHETER WERE REMOVED. THE PAIN CONTINUED AFTER REMOVAL. THE PUMP WAS INFUSING MORPHINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115990 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention