BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4130059 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-17999
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    May 13, 2013
    Report Date
    September 4, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN FLIPPING AND WAS HOT TO THE TOUCH SINCE IMPLANT. THE HEALTH CARE PROVIDER HAD BEEN ABLE TO FLIP IT BACK TO THE CORRECT POSITION AND THE PUMP WAS ONLY SPORADICALLY HOT. THERE WERE TIMES THAT THE PATIENT COULD FEEL IT BE HOT FROM TOUCHING IT, AND OTHER TIMES SHE COULD FEEL IT FROM THE INSIDE THAT IT WAS HOT. A COUPLE OF MONTHS AGO, THE PUMP FLIPPED AND THEY WERE NOT ABLE TO FLIP IT BACK TO THE ORIGINAL POSITION. IT WAS DIFFICULT TO REFILL THE PUMP BECAUSE THE PORT WAS ON THE BACK SIDE. THE DRUG IN THE PUMP WAS MORPHINE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608183 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR