BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203166 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04697
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER, PRODUCT ID: 8590-1, LOT# N324832, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEALTH CARE PROFESSIONAL DID A DIRECT POSTERIOR/ANTERIOR ON THE PATIENT¿S ABDOMEN, AND THE PUMP WAS FOUND FLIPPED. THE ACCESS PORT WAS HEADING LEFT COUNTERCLOCKWISE. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE PATIENT OUTCOME WAS NOTED AS ¿DOING FINE.¿ THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302358 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR