BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3041328 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04869
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 11, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THIS CATHETER WAS EITHER KINKED OR BROKEN AND THE PATIENT HAD NOT RECEIVED ANY OF THE MEDICATION. THE PATIENT HAD TWO REFILLS AND EACH TIME ALL 20 MILLILITERS WAS ASPIRATED. IT WAS LATER REPORTED THIS PATIENT EXPERIENCED DRUG WITHDRAWAL IN (B)(6) OF 2012. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012 WHICH REVEALED AN OCCLUSION. FURTHER REPORTED WAS A FAILURE TO ASPIRATE THE CATHETER DUE TO AN OCCLUSION IN THE DISTAL SEGMENT. AS A RESULT, THE CATHETER WAS REVISED ON (B)(6) 2013. THIS DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE PATIENT'S MORPHINE WAS BEING TITRATED TO THE PREVIOUS 6.7 MILLIGRAMS/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143044 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention