BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3884592 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11827
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED A SEROMA AT THE PUMP SITE. LESS THAN A MONTH LATER, IT WAS REPORTED THAT THE PATIENT WAS GETTING BETTER; VERY, VERY RED AROUND AREA; IT CAME LOOSE AND MY STOMACH "BLEW UP"; SAW HEALTHCARE PROVIDER (HCP) FIVE TIMES SINCE PUMP BULGED OUT; INCISION VERY RAW; FOLLOWING UP WITH HCP. THE REPORTED CAUSE OF EVENT WAS SURGICAL DISSECTION; PATIENT EXPERIENCED TRANSIENT SUBCUTANEOUS SWELLING. THIS WAS NOTED TO HAVE RESOLVED WITH NO SURGICAL INTERVENTION NEEDED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION RECEIVED NEARLY THREE YEARS LATER REPORTED THAT WITH THE FIRST PUMP THE PATIENT HAD A BACTERIA AND THEY FIXED IT AND THEN HAD TO WAIT TWO WEEKS IN BETWEEN BEFORE GOING BACK TO THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360276 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention