BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120884 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07940
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTHCARE PROVIDER REPORTED THAT THE PATIENT¿S PUMP WAS ¿VERY FLIPPED¿; THAT IT WAS PRETTY MUCH ON ITS SIDE; THAT WHEN THEY ACCESS IT, THEY HAVE TO PUSH IT OVER. THEY FURTHER STATED THAT IT WAS ¿VERY DIFFICULT¿ TO FILL; THAT THEY WERE NOT ABLE TO ACCESS IT THEMSELVES; THAT A MORE EXPERIENCED NURSE WAS ABLE TO ACCESS IT AFTER A COUPLE OF ATTEMPTS. THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID OR MORPHINE. THE PATIENT WAS TO HAVE AN X-RAY. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. THE INDICATION FOR USE WAS SPINAL PAIN. THE CONCENTRATION AND LOT NUMBER OF THE MEDICATION WERE UNKNOWN. THE PUMP WAS POSITIONED AT A 90 DEGREE ANGLE, AND THE PATIENT WAS DENIED AN MRI DUE TO THIS. THE PUMP WAS NOT CAUSING THE PATIENT PAIN. THE PUMP POSITIONING HAD GOTTEN WORSE OVER TIME. THE HEALTH CARE PROVIDER (HCP) WAS AWARE OF THE POSITION OF THE PUMP BUT WAS NOT CONCERNED ABOUT IT. THE CAUSE OF THE ISSUE WAS UNKNOWN. FOLLOW UP WAS CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221702 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1