BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202773 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-06103
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    August 15, 2012
    Report Date
    August 15, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 10642, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE PATIENT WAS USING BINDER ALL THE TIME. ONSET DATE AS NOTED AS (B)(6) 2012. THE RESOLUTION DATE AS NOTED AS (B)(6) 2012. OTHER THAN ENCOURAGING THE PATIENT TO WEAR THE BINDER NO OTHER ACTIONS WERE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT PUMP POCKET SITE POST PROCEDURE. ON A SCALE OF 0-10, THE PATIENT IDENTIFIED IT AS A 6. THE PATIENT WAS SEEN ON (B)(6) 2012 FOR ONE WEEK FOLLOW UP, AND IT WAS NOTED THAT THE PATIENT STILL HAD PAIN AT POCKET SITE. THE ABDOMEN WAS SOFT AND NON-TENDER TO TOUCH. THE PAIN OCCURRED WITH STANDING AND BENDING. ON (B)(6) 2012, THE PATIENT WAS SEEN FOR REFILL. THE PAIN WAS SUBSIDING AND THE PATIENT WAS STILL USING TYLENOL WITH CODEINE FOR PAIN OCCASIONALLY. ABDOMEN WAS SOFT AND INCISIONS WERE CLEAN AND DRY. NO VOLUME DISCREPANCY WAS NOTED DURING THE REFILL. IT WAS REPORTED THAT AT THE VERY END OF ASPIRATING THE DRUG FROM THE RESERVOIR, THE NURSE GOT SOME OLD BLOOD THAT WAS KIND OF ¿DARK AND COAGULATED.¿ THE BLOOD WAS ¿NOT DILUTING AND KIND OF THROWN ALL TOGETHER.¿ THERE WERE ¿A LOT OF SWELLING AND BRUISING¿ AT THE PUMP SITE NOTED. THE PUMP WAS BEING USED TO DELIVER REMODULIN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303077 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1