BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3870923 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11529
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 21, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER ISSUE, DYE STUDY SHOWED NO FLOW AT THE CATHETER TIP AND ¿A BOLUS OF LOCAL THRU SIDE-PORT DID NOT PRODUCE ANY NUMBNESS IN FEET.¿ THE LOCATION OF THE CATHETER ISSUE WAS UNKNOWN. THERE WAS A REVISION SCHEDULED FOR (B)(6) 2014. THE PUMP SYSTEM WAS DELIVERING DILAUDID. IT WAS NOTED THAT THEY WERE TITRATING TO EFFECT POST-REVISION. THERE WAS NO ALLEGED PRODUCT ISSUE AGAINST THE PUMP. IT WAS REPORTED THAT THERE WAS LESS THAN 50% THERAPY RELIEF AND ¿CA PAIN.¿ PATIENT¿S STATUS AT THE TIME OF REPORT WAS ¿ALIVE-NO INJURY.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP SEGMENT OF THE CATHETER WAS REVISED ON THE DAY OF REPORT ALONG WITH A CATHETER DYE STUDY CONFIRMING EVERYTHING WAS PATENT. IT WAS NOTED THAT THEY WERE ALSO CHANGING OUT DRUGS AND A ¿RINSE WAS DONE.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PRIME OF THE CATHETER WAS IN PROGRESS AT THE TIME OF THE CALL. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A LOSS OF THERAPY, SO THERE WAS A CATHETER DYE STUDY ATTEMPTED BUT IT WAS UNSUCCESSFUL. IT WAS NOTED THE DATE THE ISSUE BEGAN WAS UNKNOWN. IT WAS ALSO NOTED THAT THE PATIENT HAD A RECENT BARIUM STUDY. THE PUMP POCKET AREA WAS OPENED UP WITH THE CATHETER STILL INTACT BUT THOUGHT ¿THE COLLECT AREA MAY HAVE BEEN LEAKING BUT MAYBE NOT.¿ IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE PATIENT WAS REFRACTORY TO THE NARCOTICS. IT WAS NOTED THAT ON THE DAY OF REPORT A BRAND NEW CONNECTOR PIECE WAS ADDED TO THE EXISTING CATHETER AND THE CATHETER WAS CONFIRMED AS PATENT. THE PUMP WAS INFUSING DILAUDID AND MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS BEING TITRATED PER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350176 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention