BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3121546 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07954
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 15, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAST TWO TIMES THE PATIENT WAS AT THE HEALTHCARE PROVIDER¿S (HCP) OFFICE SHE HAD RUN OUT OF MEDICATION FOR TWO WEEKS AND NO PUMP ALARM OCCURRED. THE PATIENT STATED ¿THEY GOT THE MACHINE DATA INCORRECT AND I HAD RUN OUT¿. THE PATIENT STATED THAT SHE KNEW SOMETHING WAS WRONG BECAUSE SHE WAS TAKING MORE BREAKTHROUGH MEDICATION THAN USUAL. THE PATIENT STATED SHE WAS GOING THROUGH WITHDRAWALS FROM THE MEDICATION IN THE PUMP BUT THE BREAKTHROUGH MEDICATION KEPT HER FROM ANYTHING SEVERE. THE PATIENT HAD AN APPOINTMENT WITH THE PHYSICIAN SCHEDULED FOR (B)(6) 2013. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224126 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1