BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242360 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12142
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 1, 2013
    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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO HAVE THEIR FIRST REFILL DONE ONE MONTH AFTER PUMP WAS IMPLANTED AND THE HEALTH CARE PROVIDER (HCP) REALIZED AT THAT TIME THAT THE PUMP HAD FLIPPED. THE HCP ENDED UP MANUALLY FLIPPING IT BACK. FROM THAT POINT, THE PUMP CONTINUOUSLY FLIPPED 10-12 TIMES A DAY. THE PUMP WAS SUPPOSED TO BE REVISED IN (B)(6) 2013 HOWEVER THE PATIENT ENDED UP WITH A URINARY TRACT INFECTION. THE SURGERY HAD TO BE POSTPONED UNTIL (B)(6) 2013. THE HCP THEN IN (B)(6) SURGICALLY TIED DOWN THE PUMP SO IT WOULDN¿T FLIP AGAIN. IT WAS NOTED TWO WEEKS LATER, THE PATIENT WAS IN THE HOSPITAL FOR A TOTAL KNEE REPLACEMENT. AT THAT TIME, THE PUMP WAS TURNING SIDEWAYS AND CAUSING THE PATIENT A LOT OF PAIN IN THEIR ABDOMEN ON THE LEFT SIDE AND RIGHT UNDER/BELOW THE PUMP. THE PATIENT¿S NEXT STEP WAS TO POSSIBLY CALL HER REFERRING HCP. IT WAS THEN REPORTED ¿AT THAT TIME¿ THE HCP PUT THE PATIENT IN AN ABDOMINAL BINDER BUT IT WAS NOT DOING ANY GOOD. AS OF THE DAY OF THIS REPORT, BECAUSE, THE PATIENT HAS HAD SO MANY BACK SURGERIES PRIOR TO THE PUMP, THE HCP RECOMMENDED THE PATIENT USE HER BACK BRACE TO HOLD THE PUMP IN PLACE. THE PUMP WAS STILL CONSTANTLY MOVING AND THE PATIENT WAS SPENDING ALL OF HER TIME IN BED BECAUSE OF HER BACK PAIN AND THE PUMP MOVING. THE PATIENT WAS CURRENTLY WORKING WITH HER HCP REGARDING THE BACK PAIN AND INCREASING THE DOSAGE. IT WAS NOTED ¿THIS ISSUE¿ WAS CURRENTLY BEING ADDRESSED. THE PATIENT BELIEVED SHE WAS NOW WORSE OFF THAN BEFORE SHE GOT THE PUMP. IT WAS NOTED, THE PATIENT HAD TRIED TO SEE HER HCP ON 2013 (B)(6) HOWEVER, HE WAS TOO BUSY TO SEE HER AND ALSO THAT THE HCP HAD TAKEN THE PATIENT¿S ORAL MEDICATIONS DOWN FROM ¿190 TO 140¿.THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342519 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention