BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2934742 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01107
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REFILL APPOINTMENT, A MOTOR STALL WAS RECORDED ON (B)(6) 2012, AND A MESSAGE OF 'STOPPED PUMP PERIOD EXCEED TUBE SET' MESSAGE WAS RECORDED ON (B)(6) 2012. THE PATIENT DENIED HEARING ANY ALARM, ANY WITHDRAWAL SYMPTOMS, OR ANY CHANGE IN ANALGESIA. THE PUMP WAS SET TO MINIMUM FLOW, THE PUMP WAS REFILLED, AND THE ANTICIPATED RESERVOIR VOLUMES WERE APPROXIMATELY WHAT WERE EXPECTED. THE PUMP WAS REINTERROGATED AND A MOTOR STALL RECOVERY WAS THEN RECORDED IN THE EVENT LOGS. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) STUDY ABOUT ONE MONTH PRIOR TO THE DATE OF THE REPORT. THE PUMP SYSTEM WAS BEING USED TO DELIVER HYDROMORPHONE, CLONIDINE, AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41499 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1