BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3103262 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07475
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 13, 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
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MOTOR STALL OCCURRED ON (B)(6) 2013 AT 12:10. THE PATIENT HAD REPORTED HEARING THE PUMP ALARMING. THE CALLER CONFIRMED THE MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY. THE PATIENT WAS IN SEVERE PAIN THAT STARTED THE NIGHT PRIOR TO THE REPORT AND WAS CURRENTLY GOING THROUGH WITHDRAWAL. THE PATIENT HAD RECENTLY HAD AN X-RAY BUT NO MRI. THE HEALTHCARE PROVIDER (HCP) WAS GOING TO GIVE THE PATIENT ORAL MEDICATION. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. 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
    203391 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1