BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3961758 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13604
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PUMP WAS INITIALLY IMPLANTED, THE PATIENT WAS TOLD THAT IT WOULD LAST 10 YEARS. HER PHYSICIAN WANTED TO ¿CHANGE OUT HER PUMP QUICKLY, ABOUT 3-4 MONTHS¿. THE PATIENT WAS SCHEDULED FOR A PUMP REPLACEMENT; IT WAS UNCLEAR IF IT WAS IN EARLY (B)(6). THE PATIENT WAS A PETITE WOMAN, SO THEY WERE GOING TO BE REPLACING THE PUMP WITH A SMALLER SIZE; SHE CURRENTLY HAD THE LARGER PUMP. WITH THE LARGE PUMP, THE PATIENT COULD FEEL THE PUMP MOVING UP/DOWN AND STICKING OUT MORE. IT WAS NOTED THAT THE PATIENT HAD BACK SURGERY ON (B)(6). THE DEVICE SYSTEM WAS DELIVERING DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439330 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention