BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3252093 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12413
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿NEEDED AN MRI (MAGNETIC RESONANCE IMAGING) TO CHECK THE TIP OF HER CATHETER FOR GRANULOMA.¿ IT WAS NOT REPORTED WHAT THE SYMPTOMS WERE RELATED TO CHECKING FOR GRANULOMA OR WHEN THOSE SYMPTOMS BEGAN. THE PATIENT HAD BEEN TREATED FOR CELLULITIS OF THE LEFT FOOT AND LEG AS REPORTED IN MANUFACTURER REPORT #3004209178-2013-08757. IT WAS NOTED BY THE HEALTHCARE PROVIDER (HCP) THAT THE PATIENT HAD ¿MOVED UP NORTH AND DROVE DOWN FOR HER LAST REFILL ,¿ THE PATIENT WAS ¿LIKELY NOT COMING BACK,¿ THAT THE PATIENT NEVER SCHEDULED THE MRI AND THE HCP HAD NOT HEARD FROM THE PATIENT ¿IN A WHILE.¿ THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AN MRI WAS BEING PERFORMED TO CHECK THE TIP OF THE CATHETER FOR A POTENTIAL PROBLEM; IT WAS THOUGHT THAT THE ¿TIP WAS CLOGGED OR SOMETHING¿. IT WAS LATER REPORTED THAT AN MRI WAS DONE AND INDICATED NO GRANULOMA PRESENT. THE PATIENT HAD HAD AN INCREASE IN PAIN. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353428 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other