BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973793 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13850
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8578, LOT# N113069, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY; 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 THE PATIENT'S PUMP HAD POSSIBLY FLIPPED. ADDITIONAL INFORMATION INDICATED THAT X-RAY CONFIRMED A FLIPPED PUMP. NO PATIENT SYMPTOMS WERE REPORTED. ON (B)(6) 2014, A REVISION WAS PERFORMED. DURING THE REVISION, THE PUMP WAS DISCONNECTED AND FLIPPED BACK TO THE PROPER POSITION AND SECURED USING LIGATURES TO PUMP LOOPS. THE PATIENT¿S STATUS WAS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450485 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention