BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3150765 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08752
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE FOLLOWING INFORMATION WAS NOT RELEVANT TO THIS EVENT: "THEY WERE UNABLE TO ASPIRATE THROUGH THE CAP POST IMPLANT, ALTHOUGH ABLE TO ASPIRATE THROUGH THE CAP ONCE THE CONNECTION OF THE CATHETER AND PUMP WERE COMPLETE DURING THE IMPLANT."

    Description of Event or Problem · 1

    (B)(6) 2013 - ((B)(4),REP): IT WAS REPORTED THERE WAS A CATHETER DISRUPTION. DURING THE INITIAL IMPLANT THE CATHETER WAS SECURED WITH ANCHOR AND DEPLOYMENT TOOL. THE CATHETER COULD NOT BE ASPIRATED AND NEEDED TO BE REMOVED AND RE-INSERTED. THE CATHETER WAS BROKEN IN THE PROCESS OF REMOVING THE DEPLOYMENT TOOL. THE LOCATION OF THE ISSUE WAS NOTED AS THE CATHETER TRACK AT THE ANCHOR SITE. A NEW CATHETER WAS OPENED AND INSERTED SUCCESSFULLY TO FINISH THE CASE. THE BROKEN CATHETER WAS NEVER IMPLANTED. THE PATIENT STATUS AS OF THE TIME OF THIS REPORT WAS NOTED AS "ALIVE- NO INJURY/NO ADVERSE EVENT." THE PUMP WAS BEING USED TO DELIVER MORPHINE.

    Description of Event or Problem · 1

    IT WAS STATED THE THEY WERE UNABLE TO ASPIRATE THROUGH THE CAP (CATHETER ACCESS PORT) POST IMPLANT ALTHOUGH ABLE TO ASPIRATE THROUGH THE CAP ONCE THE CONNECTION OF THE CATHETER AND PUMP WERE COMPLETE DURING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251068 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR