BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2926559 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00866
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 19, 2012
    Report Date
    October 1, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L75130, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THEIR PUMP STARTED ALARMING ON (B)(6) 2012. THE PATIENT HEARD A SINGLE TONED ALARM EVERY HOUR FOR SEVEN DAYS. TELEMETRY HAD NOT BEEN PERFORMED. STARTING ON (B)(6) 2012 THE PATIENT STARTED HEARING A CRITICAL ALARM. THE PATIENT EXPERIENCED 'A LOT OF PAIN' AND DIFFICULTY WALKING. THE PATIENT INDICATED THAT THAT SHE HAD NOT BEEN GETTING ANY PAIN RELIEF. THE PATIENT WAS SEEKING A PHYSICIAN TO FILL THEIR PUMP. THE PUMP WAS DELIVERING LIDOCAINE AND TWO UNKNOWN MEDICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING DIFFICULTY FINDING A HEALTH CARE PROFESSIONAL TO FILL HER PUMP AS THE DATE OF THIS REPORT AND THE PUMP HAD BEEN EMPTY SINCE (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HADN'T HAD MEDICATION SINCE (B)(6) 2012. THE PUMP BEEPED EVERY HOUR. THE REPORTER DESCRIBED THE ALARM HAS A CRITICAL ALARM. AT THE TIME OF THE REPORT, THE PATIENT WAS STILL HAVING DIFFICULTY FINDING A PHYSICIAN TO FILL HER PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID, LIOCAINE, AND AN UNKNOWN DRUG. IT WAS LATER REPORTED THAT THE CRITICAL ALARM WAS DUE TO AN EMPTY RESERVOIR, HOWEVER IT WAS NOT STATED THAT TELEMETRY CONFIRMED THIS. THE ALARM COULD BE HEARD "ACROSS THE ROOM" BECAUSE THE PATIENT LOST 51 POUNDS AND THE PUMP STUCK OUT A LOT. WHEN THE PATIENT LEANED ON THE COUNTER, THE PATIENT COULD FEEL THE PUMP. IT WAS UNCLEAR IF THIS CAUSED THE PATIENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31982 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR