BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3372463 · Received September 27, 2013

    Report

    Report Number
    3004209178-2013-17060
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Report Date
    September 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A REFILL APPOINTMENT THE LOGS SHOW ELECTIVE REPLACEMENT INDICATOR (ERI) HAS OCCURRED. THE PUMP WILL NEED TO BE REPLACED (B)(6) 2013. THE PATIENT WAS NOT HAPPY AND WAS CONCERNED THAT SHE COULDN¿T GET A NEW PUMP AND WOULD HAVE TO GO BACK TO ORAL MEDICATION. THE PATIENT HAS A REFILL APPROXIMATELY ONCE A MONTH. THE PUMP WAS DELIVERING MORPHINE AND BUPIVACAINE. IT WAS LATER REPORTED THE PUMP HAD A CRITICAL ALARM. THE PUMP WAS SHOWING A SUSPECTED PREMATURE ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2013 AND SUGGESTS THE PUMP TO BE REPLACED BY (B)(6) 2013. THERE WERE NO SYMPTOMS RELATED TO THIS EVENT. THE PLAN WAS FOR THE PUMP TO BE REINTERROGATED AT THE REFILL ON (B)(6) 2013. THE PATIENT STATUS WAS ALIVE - NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491008 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR