BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3838485 · Received May 29, 2014

    Report

    Report Number
    3004209178-2014-09786
    Event Type
    Injury
    Date Received
    May 29, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFLAMMATORY MASS (IM) THAT WAS "LIKE 3 INCHES LONG, 1 1/2 INCHES WIDE" AND STUCK UP AN INCH AND A HALF OFF THE PATIENT'S BACK. IT WAS NOTED THAT THE PATIENT HAD THE IM SINCE IMPLANT BUT IT WAS GETTING WORSE AND WORSE. THEY WERE REPORTEDLY GOING TO DO A DYE STUDY THE FOLLOWING DAY TO INVESTIGATE IT. THE PATIENT REPORTEDLY HAD "EVERY SYMPTOM", INCREASED PAIN, HAVING TO TURN THE PUMP UP TO CONTROL THE PAIN. THEY WERE REPORTEDLY "TRYING TO HANDLE IT" AND WERE "ON TOP OF IT". THE PUMP WAS INFUSING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315725 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention