BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2871690 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11790
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 16, 2012
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEROMA AROUND THE PUMP SITE (LEFT SIDE) SHORTLY AFTER SURGERY. THE SEROMA WAS DRAINED TWICE ("140CC/180CC") BY AN INTERVENTIONAL RADIOLOGIST ; HOWEVER BOTH TIMES THE FLUID RETURNED WITHIN A WEEK EVEN THOUGH PATENT WAS WEARING AN ABDOMINAL BINDER 24/7. PER REPORTER "THIS STICKS OUT SEVERAL INCHES FROM THE WAIST MAKING IT NEARLY IMPOSSIBLE TO FIND CLOTHING AND INTERFERED WITH DAILY ACTIVITIES". IT WAS LATER REPORTED THAT BETWEEN (B)(6) 2012 AND (B)(6) 2012 PATIENT HAD VISITED HER HEALTHCARE PROVIDER AND THE DRUG IN THE PUMP WAS CHANGED TO BUPIVACAINE. AFTER THE REFILL PROCEDURE THE SEROMA RESOLVED IN THE NEXT 3 DAYS AND PATIENT WAS NOT WEARING AN ABDOMINAL BINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention