BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4243486 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21318
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 22, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, LOT# N186493003, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS REFILLED ON (B)(6) 2014. THE REPORTER AND PATIENT STARTED HEARING THE ¿EMERGENCY ALARM¿ ON THURSDAY THE WEEK PRIOR TO THIS REPORT. THEY WENT TO THE DOCTOR ON MONDAY AND THE "COMPUTER SAYS THAT IT'S RUNNING FINE¿. AT THAT TIME, THEY FILLED THE PUMP AND IT "WOULDN'T LET WHOLE AMOUNT OF MEDICINE IN" AND THE HCP (HEALTHCARE PROFESSIONAL) SAID THE PUMP "FROZE UP", SO THEY ONLY FILLED IT HALF WAY. AN HOUR AFTER THEY LEFT THAT DAY, THE "EMERGENCY ALARM" WENT OFF AGAIN AND IT WAS STILL GOING OFF EVERY HOUR. AS OF THE DATE OF THIS REPORT, THE PUMP WAS STILL ALARMING. THE PATIENT¿S LEGS WERE SHAKING SO BAD AND WERE ¿SO HEAVY¿ THAT THE PATIENT COULDN¿T ¿PICK THEM UP¿; THE PATIENT WAS CURRENTLY UNABLE TO WALK. WITHOUT THE PUMP, THE PATIENT WAS IN AN ELECTRIC WHEELCHAIR, BUT WHEN THE PUMP WAS WORKING THE PATIENT COULD WALK. THE REPORTER HAD CONTACTED THE PHYSICIAN¿S OFFICE MULTIPLE TIMES, BUT HAD BEEN UNABLE TO SPEAK WITH THE OFFICE MANAGER OF THE PHYSICIAN. THEY WERE PLANNING TO GO INTO TOWN ON THE AFTERNOON OF THIS REPORT AND WERE GOING TO IN TO THE HCP¿S OFFICE. THE DEVICE SYSTEM WAS DELIVERING BUPIVACAINE, BACLOFEN, AND DILAUDID. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. 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
    727270 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR