BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203135 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04452
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 26, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD THEIR CATHETER ¿WORKED ON¿ ON (B)(6) 2011. THEY STATED THAT WHEN THEY HAVE HAD THEIR PUMP FILLED, THEY ¿CONSISTENTLY TAKE OUT A LOT OF MEDICATION¿. ON (B)(6) 2011 THEY DID A DYE STUDY TEST THAT LOOKED NORMAL, BUT IT FOUND THAT THE CATHETER WAS ¿BEING HELD UP BY FLESH AROUND IT¿. THE PATIENT STATED THAT THE PUMP HAD TURNED AND THE CATHETER GOT DISLODGED ON (B)(6) 2011. A HEALTHCARE PROVIDER LATER REPORTED THAT THE CATHETER WAS NOT CHANGED OUT ON (B)(6) 2011, THE DATE THE PUMP WAS CHANGED. THE CATHETER WAS STILL IN USE AND IMPLANTED ACCORDING TO THE NURSE. THEY STATED ¿BOTTOM LINE THE PATIENT IS FINE¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED BECAUSE IT WAS ¿NOT GETTING THE RIGHT DOSAGE.¿ THE DEVICE SYSTEM WAS BEING USED TO DELIVER FENTANYL AND BUPIVACAINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302711 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention