BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3932641 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12978
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 23, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL. IT WAS NOTED ¿ABOUT THIS TIME LAST YEAR¿ THE PATIENT HAD A TERRIBLE FLU OR VIRUS, BUT BECAUSE THE PATIENT WAS HARD OF HEARING SOMEONE ¿GAVE ME THE WRONG FILL DATE¿ AND THE PATIENT WAS IN THE EMERGENCY ROOM (ER) WITH ELEVATED BLOOD PRESSURE. IT WAS FURTHER REPORTED ¿THEY THOUGHT I WAS HAVING A STROKE¿ AND THE PATIENT WAS IN WITHDRAWAL FOR THREE DAYS. IT WAS REPORTED THIS HAPPENED BECAUSE THE PATIENT COULD NOT HEAR HER ALARM BEEPING. IT WAS ALSO REPORTED THEY TRIED TO TURN THE ALARM UP IN THE OFFICE, BUT THE PATIENT WAS REALLY HARD OF HEARING SO ¿I COULD NOT HEAR IT AND I GOT A VIRUS AND IT TOOK MY HEARING AND THE KIND THAT I HAVE WON¿T BE HELPED BY A HEARING AID.¿ THE PATIENT WAS GOING TO GET A STETHOSCOPE AND CHECK HER PUMP A FEW TIMES A DAY. IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER. 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
    409570 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR