BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3122817 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08001
    Event Type
    Malfunction
    Date Received
    May 21, 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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN UPDATING THE PATIENT'S PERSONAL THERAPY MANAGER (PTM) THE EMPTY RESERVOIR ALARM OCCURRED WITH 27.5ML INFUSED. IT WAS REPORTED THAT THEY CHANGED THE RESERVOIR VOLUME TO 40 THEN BACK TO 11.5 WITHOUT ANY ISSUE. ALL PROGRAMMING ISSUES WERE RESOLVED. THERE WAS NO PATIENT OR THERAPY ISSUE REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223797 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1