BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3201398 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MEDTRONIC NERUOMODULATION RICE CREEK
    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 PRODUCT: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP HAD BEEN ALARMING FOR THE LAST FEW DAYS. THE PATIENT HAD A REFILL ON (B)(6) 2012. THE PATIENT HEARD THE BEEPING EVERY 15-20 SECONDS FOR 20 MINUTES. ON THE DATE OF THIS REPORT, THE PUMP WAS INTERROGATED AND A ¿DOUBLE BEEP¿ WAS NOTED. AN ALARM TEST WAS PERFORMED. DURING THE ALARM TEST, A MESSAGE POPPED UP AND SHOWED ¿MEMORY ERROR¿ AND THEN ¿PUMP STOPPED.¿ THE PUMP WAS REPROGRAMMED TO START AGAIN. ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD EXPERIENCED A SHOCK WHILE FIXING A LAMP. THE MESSAGE THAT HAD APPEARED ON THE PROGRAMMER INDICATED AN ¿ELECTIVE REPLACEMENT INDICATOR (ERI).¿ IT WAS NOTED THAT DUE TO ¿ERI¿ MESSAGES AT EARLIER REFILLS, THE PHYSICIAN HAD ALREADY BOOKED A PUMP REPLACEMENT. THE PUMP WAS REPLACED AND THE PATIENT WAS DOING ¿GREAT.¿ THE DRUG IN THE PUMP WAS FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303146 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NERUOMODULATION RICE CREEK 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR