BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4211461 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20632
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST 3 WEEKS, THE PATIENT NOTICED BEING STIFFER AND THE PUMP STICKING OUT. THE PUMP USUALLY LIED FLAT, BUT NOW IT POKED OUT. THE PUMP HAD BEEN ¿FEELING WEIRD¿ AND THE PATIENT HAD AN EPISODE THE WEEK PRIOR TO THE REPORT; THE PATIENT FELT CONFUSED. THE PATIENT DESCRIBED IT AS AN ¿OUT OF IT SENSATION¿ AND ADDED THAT SHE HAD ONLY FAINTED ONCE IN HER LIFE. THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 BECAUSE SHE DID NOT FEEL RIGHT. AT THIS APPOINTMENT, THE PATIENT DETERMINED TO BE DEHYDRATED. IT REPORTEDLY TOOK THE HCP AWHILE TO LOCATE THE PUMP AND DIFFICULTLY WAS ENCOUNTERED TRYING TO INTERROGATE THE PUMP. IT WAS NOTED THAT THIS ALSO OCCURRED THE LAST TWO TIMES THE PATIENT WAS SEEN. THE PUMP WAS LAST REFILLED THE DAY PRIOR TO THE REPORT. AT THAT TIME, IT WAS STATED THAT THE NEEDLE WAS PUT IN TWICE AND THE HCP WAS UNSUCCESSFUL IN FINDING THE RESERVOIR. THE PROCESS REPORTEDLY TOOK 2 HOURS. THE PATIENT FELT SHE ¿PUSHED IT¿ AND THOUGHT THE PUMP WAS NOT SUPPOSED TO BE REFILLED UNTIL (B)(6) 2014. THE PATIENT ASKED FOR THE REFILL EARLY BECAUSE SHE FELT FUNNY. THE PUMP WAS SUBSEQUENTLY NOT REFILLED AND DAILY DOSE WAS DECREASED BY 20% (FROM 113 TO 92 MCG/DAY). THE PATIENT ALSO HAD FALLEN AROUND THE TIME PERIOD OF THE ISSUE; THE DATE WAS UNKNOWN. THE PATIENT DID NOT GET HURT FROM THE FALL, BUT IT WAS NOTED AS A ¿LITTLE BIT HARDER FALL.¿ THE PATIENT WAS UNSURE IF SHE NOTIFIED THE HCP ABOUT THE FALL. ULTRASOUND AND X-RAY (SENT TO A DIFFERENT FACILITY) WERE PERFORMED AND THE PUMP WAS CONFIRMED TO BE FLIPPED. THE PATIENT WAS NOTIFIED THE NIGHT PRIOR TO THE REPORT THAT THE PUMP WAS INDEED FLIPPED. THE PATIENT WAS SCHEDULED FOR A PUMP REVISION THE NEXT DAY. THE PUMP WAS USED TO DELIVER BACLOFEN (UNKNOWN, DEVICE IMPLANT QUERY LISTED THE DRUG AS LIORESAL). NO OUTCOME WAS 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
    693266 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention