BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3002839 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03677
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL #(B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THERE WAS A PROBLEM CONFIRMING CEREBROSPINAL FLUID (CSF) FLOW WHEN ASPIRATING THE CATHETER. THE PHYSICIAN PLACED THE CATHETER, GOT GREAT CSF FLOW AND ANCHORED. WHEN THEY WENT TO CHECK CSF FLOW AGAIN, THERE WAS NONE THERE. THE PHYSICIAN THEN DID A DYE STUDY AND TOOK THE CATHETER OUT. THE FLUID WAS GOING INTO THE CATHETER, BUT WAS NOT ABLE TO BRING ANY OF IT BACK OUT. THE PHYSICIAN PUT THE CATHETER BACK IN, GOT GOOD FLOW, AND WHEN DOUBLE CHECKING AFTER REMOVING THE NEEDLE, BUT BEFORE ANCHORING, THERE WAS NO CSF FLOW. THE PHYSICIAN FLUSHED THE CATHETER WITH SALINE PRIOR TO PERFORMING THE DYE STUDY AND NOTHING CAME BACK WITH ASPIRATION. IT WAS NOTED THAT SINCE THE SECOND DYE STUDY CONFIRMED THE MEDICATION WAS COMING OUT OF THE END OF THE CATHETER; THE PHYSICIAN WAS GOING TO PROCEED WITH THE IMPLANT. THE PUMP SYSTEM WAS DELIVERING LIORESAL (BACLOFEN). IT WAS ADDITIONALLY REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT SINCE THE CATHETER WAS IMPLANTED. THE HEALTH CARE PROVIDER (HCP) FELT THE CATHETER TIP WAS INCORRECTLY PLACED THE FIRST TIME IT WAS IMPLANTED. THE PATIENT'S CATHETER WAS THEREFORE REVISED. THE PATIENT'S LIORESAL DOSE AT THE TIME OF THE EVENT WAS 100 MICROGRAMS (MCG)/DAY; HOWEVER, IT WAS REDUCED TO 25 MCG/DAY UNTIL THE PATIENT'S CATHETER WAS REVISED. IT WAS ALSO REPORTED THAT THE PATIENT'S THERAPY HAD BEEN EFFECTIVE SINCE THE CATHETER REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105756 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention