BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2935528 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01125
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 7, 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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED HER REFILL ON (B)(6). THE PATIENT'S LOW RESERVOIR ALARM DATE WAS (B)(6), BUT THE PATIENT WAS NOT REFILLED UNTIL (B)(6). AT THE TIME OF THE REFILL, THE PATIENT PRESENTED WITH INCREASED TONE AND ITCHINESS. GIVEN THE PUMP'S FLOW RATE AND RESERVOIR CAPACITY, IT WAS STATED THAT THE PUMP RESERVOIR WAS LIKELY EMPTY, BUT THIS COULD NOT BE CONFIRMED. THE DRUG USED IN THIS SYSTEM WAS LIORESAL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LOW RESERVOIR ALARM HAD BEEN SOUNDING. THE INCREASED TONE PREVIOUSLY REPORTED WAS IN THE PATIENT¿S LOWER EXTREMITIES. THE PUMP WAS REFILLED AND ORAL PERIACTIN WAS ORDERED. IT WAS REPORTED THE PATIENT CALLED LATER THAT DAY AND THE ITCHING HAD DECREASED. THE OUTCOME TO THE PATIENT WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40662 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1