BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2900389 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00269
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 11, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD BEEN NEXT TO A FLUOROSCOPIC COMPUTER COMPONENT FOR THE DYE STUDY. THE CLINICIAN PROGRAMMER WAS IN THE PROCESS OF UPDATING THE PUMP WITH A PRIMING BOLUS COMMAND WHEN THE FLUOROSCOPIC COMPUTER WAS TURNED OFF. AT THAT TIME, THE PROGRAMMER BEEPED AND DISPLAYED THE PUMP MEMORY ERROR. AFTER CHANGING LOCATIONS, THE PUMP WAS SUCCESSFULLY UPDATED WITH NO PROBLEMS. AT THE TIME OF REPORT, THE PATIENT WAS FINE AND HAD BEEN RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN EXPERIENCING INCREASED PAIN DESPITE DOSING INCREASES. THERE WERE NO ALARMS AND NO VOLUME DISCREPANCIES. A DYE STUDY WAS DONE (B)(6) 2012 AND NO PROBLEM WAS FOUND. THEY WERE PLANNING TO CHANGE THE PATIENT TO FLEX DOSING AND SEE IF THAT HELPED. WHEN THEY WERE UPDATING THE PUMP TO THE NEW DOSING DATA AFTER THE DYE STUDY, TELEMETRY WAS INCOMPLETE AND SHOWED A MEMORY ERROR; THE PUMP MEMORY ERROR ALARM WAS OCCURRING. THE PUMP WAS RE-INTERROGATED AND FOUND TO BE IN STOPPED PUMP MODE; IT HAD BEEN OFF FOR 14 MINUTES. THERE WERE SOURCES OF EMI PRESENT. THEY MOVED TO A DIFFERENT ROOM TO AVOID EMI AND WERE GOING TO REPROGRAM THE PUMP. THE DEVICE SYSTEM WAS DELIVERING BUPIVACAINE AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6575 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1