BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2823355 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10023
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PROGRAMMER: MODEL: 8832, SERIAL# (B)(4); CATHETER: MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED; THE PATIENT REPORTED THAT THEY DID NOT HAVE ANY FURTHER CONCERNS WITH THEIR DEVICE OR THERAPY AND IT WAS NOTED THAT ¿EVERYTHING WAS GREAT.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING THE MEDICINE AND WHEN THE HEALTHCARE PROVIDER (HCP) REMOVED THE MEDICINE, THERE WAS A "LOT OF MEDICINE COMING OUT". IT WAS UNCLEAR IF THE PUMP WAS ALARMING; IT WAS STATED THAT PER THE HCP PUMP MAY BE ALARMING AND THAT IT MAY BE TIME TO SWITCH PUMP, GET IT OUT. AT THE LAST REFILL THERE WAS NO VOLUME DISCREPANCY AND PER REPORTER "DRAWBACK OF MEDICINE WAS PERFECT, JUST A LITTLE BIT IN THERE". HOWEVER, AT THREE REFILLS PRIOR THAT, HCP WITHDREW "HALF OF THE HUGE SYRINGE"; "EITHER PATIENT NOT USING IT AS OFTEN OR SOMETHING WAS HAPPENING" WAS INDICATED. PATIENT WAS NOT GETTING RELIEF. IT WAS STATED THAT THE HCP WOULD CONTINUE TO MONITOR THE PUMP LOGS/ALARM AND ERI (ELECTIVE REPLACEMENT INDICATOR). DRUG DELIVERED VIA THE DEVICE WAS FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1