BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3230277 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11867
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 25, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED THAT THE CATHETER HAD DISCONNECTED FROM THE PUMP. THE PATIENT HAD SURGERY ON (B)(6) 2013 TO PUT A NEW CATHETER IN.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD THEIR PUMP PLACED ON (B)(6) 2013, AND THEN THE CATHETER ¿SLIPPED OUT COMPLETELY,¿ SO THEY HAD TO GO BACK ON (B)(6) 2013 TO HAVE IT REINSERTED. THEIR PHYSICIAN HAD PERFORMED AN X-RAY FOR PLACEMENT AND THEY SAW THAT THE CATHETER WAS NOT IN PLACE. THEY LATER NOTED THAT ¿THEY PUT A COMPLETE NEW CATHETER IN¿. THEY NOTED THEY WERE GETTING THE PUMP FILLED TOMORROW. THEIR PUMP WAS TO BE FILLED WITH FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention