BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3930171 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12928
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    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 PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8781, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT SAW ERROR CODE 8476 ON THE PTM WHEN SHE WAS TRYING TO GET A BOLUS. THE PATIENT WAS REPORTEDLY ABLE TO GET A BOLUS LATER. THE PATIENT CONFIRMED THAT THERE WAS NO CODE ON THE PTM AT THE TIME OF REPORT. THE PATIENT WAS REPORTEDLY UNABLE TO GIVE HERSELF ANOTHER BOLUS ON THE DAY OF REPORT. THE PATIENT'S PUMP WAS INTENDED TO INFUSE MORPHINE, BUPIVACAINE, AND CLONIDINE. IT WAS LATER REPORTED THAT AGAIN THE PATIENT TRIED TO GIVE A BOLUS AND GOT THE ERROR CODE 8476. THE PATIENT REPORTED KEPT ON PUSHING BUTTONS AND THEN RECEIVED A BOLUS. IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR THE MANUFACTURER'S REPRESENTATIVE. IT WAS NOTED THAT THERE WERE APPOINTMENT DATES OF (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING INFORMATION PREVIOUSLY REPORTED UNDER THIS MANUFACTURER REPORT # 3004209178-2014-12928 {THE PATIENT WAS REPORTEDLY UNABLE TO GIVE HERSELF ANOTHER BOLUS ON THE DAY OF REPORT} PERTAINS TO A DIFFERENT EVENT AND IS NOT APPLICABLE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406096 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR