BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3820989 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09265
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    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
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N345586, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP STALL RECOVERED AND WAS STALLED FOR LESS THAN 24 HOURS. IT WAS NOTED THAT THERE WAS ONLY ONE MOTOR STALL NOTED IN THE EVENT LOGS. THE PUMP WAS INTERROGATED FIVE TIMES. THE CAUSE WAS TO BE DUE TO AN MRI. THE EVENT LOGS SHOWED THAT THE MOTOR STALL OCCURRED ON (B)(6) 2014 AT 11:30 AND RECOVERED ON THE SAME DAY AT 14:49. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CONFIRMED MOTOR STALL AT 11:30 CAUSED BY AN MRI BUT THAT NO RECOVERY HAD BEEN RECORDED. THE PUMP WAS INTERROGATED 30 MINUTES AND 10 MINUTES PRIOR TO THE REPORT. IT WAS NOTED THAT THERE WERE NO NOTABLE ALARMS. THE PATIENT WAS REPORTEDLY IN MORE PAIN THAN NORMAL FOLLOWING THE MRI AND THEY "THOUGHT THEY HEARD THREE BEEPS IN A ROW", BUT WERE UNSURE IF THE SOUND WAS COMING FROM THE PUMP OR SOMETHING ELSE. THE REPORTER HAD NOT HEARD AUDIBLE ALARMS FROM THE PUMP. THE MOTOR STALL RECOVERY MESSAGE WAS STILL NOT LOGGED 90 MINUTES AFTER THE MRI. THE PUMP WAS DELIVERING CLONIDINE, BUPIVACAINE, AND DILAUDID. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300396 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR