BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4110840 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17551
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CHANGE IN THERAPY EFFECT. THE PATIENT FELT LIKE THEIR PUMP WAS NOT WORKING. THE PATIENT REPORTED FEELING "JITTERY" AND AN INCREASE IN BASELINE PAIN. IT WAS ALSO NOTED THAT THE PATIENT WAS URINATING A LOT. THE PATIENT WAS TAKING ORAL PERCOCET FOR BREAKTHROUGH PAIN. THE PUMP WAS INTERROGATED, NO ALARMS WERE NOTED AND THE PATIENT DID NOT REPORT HEARING AN ALARM. THERE WAS A REFILL DONE ON 2014-08-11. THE EVENT OCCURRED SOMETIMES BETWEEN THE REFILL AND TODAY (2014 (B)(6)). IT WAS CONFIRMED THAT THERE WAS NO VOLUME DISCREPANCY NOTED AT THE REFILL ON 2014 (B)(6). IT WAS NOTED, THE MANAGING PHYSICIAN ONLY DID REFILLS AND DID NOT DO DYE STUDIES. THE PUMP SYSTEM WAS DELIVERING MORPHINE. (NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590521 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR