BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242273 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12137
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER FROM THE CATHETER ACCESS PORT DURING A DYE STUDY. THE PATIENT REPORTEDLY HAD EXPERIENCED UNDERDOSING SYMPTOMS. IT WAS NOTED THERE WAS ¿SOME QUESTION¿ OF THE PUMP CONNECTOR. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. IT WAS THEN REPORTED A CATHETER REVISION WAS SCHEDULED AND DIAGNOSTIC TESTING/TROUBLESHOOTING WAS TO BE PERFORMED IN THE FUTURE. THE PATIENT REPORTEDLY EXPERIENCED PAIN. IT WAS LATER REPORTED THE LOCATION OF THE ISSUE WAS UNKNOWN AND THE ENTIRE CATHETER WAS REPLACED. THE PATIENT WAS REPORTEDLY ¿FINE¿. IT WAS STATED THERE WAS ¿NOTHING TO RETURN¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343798 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention