BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3800213 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08732
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, LOT# N114500, IMPLANTED: (B)(6) 2008-, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# J11159R69, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT A VIBRATION AND MOVEMENT IN THE AREA OF HER PUMP DURING A MAGNETIC RESONANCE IMAGING (MRI) SCAN. IT WAS NOTED THESE SENSATIONS CAUSED HER SOME DISCOMFORT AT THE PUMP POCKET AND CONCERN. IT WAS ALSO REPORTED THE SCAN WAS ABORTED. IT WAS FURTHER REPORTED THE PATIENT WAS DOING FINE NOW WITH NO DISCOMFORT OR ANY SEQUELAE FROM THE PROCEDURE OR THE TRANSITORY SENSATION SHE FELT DURING THE SCAN. IT WAS NOTED THE ¿PUMP WAS HER FRIEND AND SHE COULD NOT GET ALONG WITHOUT IT.¿ THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE PATIENT WAS RECEIVING ADEQUATE THERAPY AT THIS TIME. THE PUMP WAS BEING USED TO DELIVER DILAUDID, BUPIVACAINE, AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278543 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR