BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3800357 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08737
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 15, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# L75111, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON THE PRIOR WEEK¿S THURSDAY, THE PUMP WAS FILLED AND, AT THAT TIME, THE PATIENT DIDN¿T FEEL RIGHT. IT WAS LATER CONFIRMED THAT THE SAME THING HAD BEEN PUT INTO THE PATIENT¿S PUMP. ON THE FOLLOWING DAY, THE PATIENT STARTING HAVING CHILLS, WAS SUBSEQUENTLY HOT, AND THEN GOT CHILLS AGAIN WHILE HER NOSE KEPT RUNNING. THE DAY AFTER THAT, THE PATIENT STARTED TO GO THROUGH WITHDRAWAL AROUND NOON. SHE BECAME ANTSY AND WAS WALKING THE FLOOR. AT THAT TIME, THE PATIENT CALLED HER NURSE, NOT KNOWING IF SHE COULD STAND IT, TO BRING HER TO THE EMERGENCY ROOM (ER) AS SHE WAS IN ¿FULL-BLOWN WITHDRAWAL¿. THE PATIENT TOOK FOUR LORAZEPAM AND THEN TOOK TWO MORE, PER NURSE RECOMMENDATION, TO HELP HER RELAX. SHE WAS THEN ABLE TO SLEEP AND DID NOT GO TO THE ER. ON THE FOLLOWING DAY, THE PATIENT DIDN¿T HAVE ANY WITHDRAWALS; HOWEVER, STARTING ON THE DAY PRIOR TO REPORT, THE PATIENT WAS GETTING CHILLS AGAIN. THE REPORTER STATED THAT THERE WAS SOMETHING WRONG WITH THE PUMP TO KEEP GOING THROUGH THIS. IN ADDITION, THE DOCTOR HAD ONLY BEEN THERE A SHORT TIME AND THE PATIENT FELT THAT HE DIDN¿T KNOW WHAT HE WAS DOING. HE DIDN¿T TALK TO THE PATIENT; HE WOULD PUT ¿THE METAL THING¿ UP TO HER AND WOULD THEN LEAVE. IT WAS STATED THAT THE PHYSICIAN WAS GIVING HER WITHDRAWAL AND ¿ALL SORTS OF THINGS¿. THE PATIENT WANTED THE PUMP MANUFACTURER TO COME AND FIX THE PUMP AND MAKE SURE THE DOCTORS ARE MAINTAINING THE PUMP AS THEY SHOULD BE. IT WAS NOTED THAT THE PATIENT WAS ONLY ON THE MEDICATION IN THE PUMP AND THAT KEPT BEING LOWERED. ON (B)(6), THEY HAD TAKEN OUT ¿5% EVERYDAY ON FUSION MODE¿. IT WAS ALSO REPORTED THAT THE PHYSICIAN GAVE HER AN EPIDURAL TWO WEEKS EARLIER. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277610 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR