BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3173664 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10452
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT'S CATHETER SITE AT THEIR BACK, HAD SWOLLEN UP PRETTY BIG, AND WAS TURNING A DARK BROWN COLOR. THE PATIENT FURTHER STATED THAT IT WAS VERY, VERY TENDER TO THE TOUCH, IT ITCHED A LITTLE, IT HAD SOMETIMES SWOLLEN UP, AND WAS REALLY PAINFUL. THE PATIENT PLANNED TO FOLLOW UP WITH THE HEALTHCARE PROVIDER. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT A CATHETER REVISION, AS THE CATHETER WAS PULLED OUT OF THE SPINE. THE REVISION DATE WAS NOT REPORTED, BUT PER THE MANUFACTURING DEVICE REGISTRY, THE PATIENT UNDERWENT A REVISION ON (B)(6) 2013. THE PATIENT OUTCOME WAS NOT REPORTED, BUT IT WAS NOTED THE PATIENT SUBSEQUENTLY UNDERWENT A SECOND REVISION FOR ANOTHER DISLODGMENT (SEE MANUFACTURER REPORT # 3004209178-2013-10446.). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID AND FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273039 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention