BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072912 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06751
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8591-38 LOT# A96788, IMPLANTED: 2007 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PUMP ALARM WAS REPORTED. IT WAS THOUGHT THE PATIENT CAME IN TO THE OFFICE BECAUSE SHE HAD DECREASES IN THERAPY. IT WAS LATER REPORTED THAT SHE CAME IN BECAUSE, SHE WAS GOING TO HAVE A BOTOX INJECTION. LOW RESERVOIR WAS ESTIMATED TO HAVE OCCURRED ON (B)(6) 2013, ABOUT A MONTH PRIOR TO THE REPORT. THE PUMP WAS INTERROGATED ON THE DAY OF THE REPORT, AND IT SAID "RESERVOIR VOLUME ZERO". THE PATIENT'S PUMP WAS NOTED TO HAVE BEEN ALARMING. THE PATIENT DID NOT SHOW SIGNS OF WITHDRAWAL. IT WAS THOUGHT THAT THE PUMP HAD BEEN EMPTY FOR ABOUT A MONTH, AND IT WAS LATER NOTED THAT THE PATIENT'S PUMP WAS EMPTY SINCE AROUND (B)(6) 2013. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL 2000 MCG/ML. IT WAS LATER REPORTED THAT EVENT WAS CAUSED BY NORMAL BATTERY DEPLETION. AN ELECTIVE PUMP REPLACEMENT WAS TENTATIVELY SCHEDULED FOR (B)(6) 2013. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173956 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1