BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3232105 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11906
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005: PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY WAS OBSERVED DURING A PUMP REFILL ON (B)(6) 2013. THE CALLER STATED "THEY PULLED OUT MORE MEDICATION THAT SHOULD HAVE BEEN." THE CALLER WAS UNSURE WHAT THE VOLUMES WERE BUT STATED THAT THE HEALTHCARE PROVIDER (HCP) CHECKED THE VOLUMES AND "IT WAS OVER THE DISCREPANCY" AND "IT WAS DOUBLE OVER LAST TIME BUT I DON'T KNOW WHAT LAST TIME WAS." THE PUMP WAS NOT ALARMING. THE CALLER INDICATED THAT AN X-RAY WAS TAKEN BUT RESULTS WERE NOT YET AVAILABLE. THE CALLER STATED "I JUST DON'T KNOW IF THE BATTERY IS SLOWLY DYING." THE PATIENT HAD BEEN "VERY, VERY SICK", HAD A LOT OF "ISSUES" AND HAD BEEN RUNNING A TEMPERATURE SINCE THE PREVIOUS WEEKEND. THE CALLER WANTED TO RULE OUT THE PUMP AS THE CAUSE OF THE PATIENT'S ISSUES. THE CALLER WAS TO CONTACT THE HCP TO HAVE THEM CONTACT TECHNICAL SERVICES. THE DEVICE SYSTEM DELIVERED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332503 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR