BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4152201 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18501
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY PROBLEM WHERE THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV) AT THE PATIENT¿S LAST REFILL. THE PUMP LOGS WERE CHECKED WHICH FOUND NO PROBLEMS. THEY PERFORMED A DYE STUDY ON (B)(6) 2014, THE RESULTS WERE NOT PROVIDED. THE PATIENT WAS COMPLAINING OF PAIN. THE REPORTER DID NOT KNOW WHEN THIS STARTED, BUT WAS TOLD IT HAD BEEN GOING ON FOR A WHILE. THE PATIENT WAS REPORTEDLY DOING GOOD, AND THAT THEY WERE INCREASING THEIR DOSE. THE PUMP SYSTEM WAS BEING USED TO INFUSE MORPHINE (UNKNOWN). NO SPECIFIC VALUES FOR VOLUMES, INTERVENTIONS OR OUTCOME 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
    630700 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR