BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2915445 · Received January 15, 2013

    Report

    Report Number
    3004209178-2013-00586
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    December 20, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A QUICK ONSET OF SPASTICITY THAT WENT "FROM HIS KNEES UP TO HIS CHEST" THEN "BEGAN IN HIS FINGERTIPS AND ACROSS HIS WING BONES." THE PATIENT WAS NOTED TO HAVE HAD PNEUMONIA, WHICH "WAS THEORIZED TO BE THE SOURCE OF SPASTICITY." THE PATIENT HAD BEEN HOSPITALIZED, GIVEN IV ANTIBIOTICS, AND SENT TO A REHABILITATION CENTER FOR ALMOST A MONTH. HE HAD BEEN WEANED OFF ORAL BACLOFEN AFTER HIS "ER EVENT," HIS PUMP DOSE WAS INCREASED, BUT THE PATIENT "GOT WORSE." THE PATIENT WAS REPORTED TO HAVE HAD A "BURNING WIRE ELECTRICAL SMELL AND TASTE IN HIS MOUTH" WITH EACH SPASTIC EVENT. HE ALSO HAD NAUSEA. A DYE STUDY WAS PERFORMED TWO DAYS AFTER HE HAD BEEN RELEASED FROM THE REHABILITATION CENTER AND INDICATED THAT THE "CATHETER WAS POTENTIALLY SHOWN TO BE DAMAGED." AT THAT TIME THE PATIENT WAS NOTED TO BE MANAGED BY ORAL BACLOFEN AND ORAL OXYCONTIN. THE PATIENT WAS REPORTED TO BE VERY SLEEPY AND FEEL "ZOMBIE LIKE" BECAUSE OF THOSE MEDICATIONS. IT WAS ALSO NOTED THAT THE PATIENT HAD WET THE BED. THE PATIENT'S HEALTHCARE PROVIDERS WANTED TO "WAIT AND WEAN HIM OFF THE PUMP" BEFORE DOING A CATHETER REVISION. IT WAS NOTED THAT THE PATIENT HAD NOT HAD A BOWEL MOVEMENT IN ONE WEEK, AND IT WAS REPORTED THAT PAIN MEDICATIONS HAVE HAD "SEVERE RAMIFICATIONS ON HIS BOWEL MOVEMENTS" BEFORE HE HAD THE PUMP. THE PATIENT'S BODY WAS NOTED TO BE ''LIMP FROM THE BACLOFEN THAT HE NEEDED.'' ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT A DYE STUDY WAS POSITIVE FOR CATHETER BREAKS WHILE AN X-RAY WAS NEGATIVE. THE REVISION WAS NOTED TO BE PENDING. THE PATIENT WAS NOTED TO HAVE VARIABLE SPASTICITY PAIN CONTROL, THOUGH THIS WAS REPORTED TO HAVE PREVIOUSLY BEEN UNDER HIS CONTROL. THE PATIENT WAS NOTED TO HAVE BEEN IN THE HOSPITAL FOR PNEUMONIA WHEN THE EVENT OCCURRED. THE MEDICATIONS USED WITHIN THE SYSTEM WERE BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22895 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R