BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202179 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00597
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    April 2, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED RETURN OF SYMPTOMS. THE PATIENT HAD BEEN HAVING PROBLEMS LIKE HER PUMP WAS NOT WORKING. THE PUMP WAS NOT HELPING THE PATIENT AT ALL LATELY. THE MEDICATION FOR EACH REFILL LASTED ABOUT SIX MONTHS. DURING THE LAST REFILL, THE MEDICATION IN PUMP RAN OUT BY A WEEK BEFORE IT WAS DUE. THIS TIME, THE PATIENT STARTED HAVING PROBLEMS ABOUT A MONTH EARLY. THE PATIENT¿S NEXT REFILL WAS SCHEDULED ON (B)(6) 2012. THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR ON (B)(6) 2012 FOR A DIFFERENT REASON. NO ALARM FROM THE PUMP WAS HEARD. DURING REFILL, THE DOCTOR WAS PULLING OUT VERY LITTLE MEDICATION. DURING THE LAST REFILL, ¿IT WAS ABSOLUTELY NOTHING.¿ THE PUMP WAS USED TO DELIVER UNKNOWN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301092 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1