BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3112345 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07648
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE WEEK AFTER A PUMP IMPLANT THE PUMP "HITS" THE PATIENT'S PANTS AND BELT; IT HITS EVERYTHING AND IT'S GOING TO RUB CONSTANTLY. THE FIRST WEEK IT WAS SWOLLEN. IT WAS QUESTIONED IF THE PUMP HAD TURNED OR "ONE OF THE THINGS BROKE LOOSE." THE PUMP WAS UPSIDE DOWN AND PATIENT INDICATED "THIS IS WRONG." THE PATIENT WAS ACTIVE. THE PUMP WAS DELIVERING LIORESAL. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOCATION OF THE PUMP WAS SLIGHTLY DIFFERENT CAUSING THE PATIENT DISCOMFORT AND CAUSING IRRITATION WHEN WEARING A BELT. IT WAS NOTED THERE WAS NO INJURY. THE PATIENT WAS GOING TO TRY TO SEE IF HE CAN TOLERATE THE PUMPS LOCATION. THE PUMP WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213195 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1