BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4182797 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19954
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 23, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED A POCKET REVISION OCCURRED ON 2014 (B)(6) DUE TO PUMP POSITIONING. IT WAS NOTED IN THE PUMPS CURRENT POSITION THE PATIENT HAD HIT IT UP AGAINST COUNTERS, ETC WHEN REACHING FOR SOMETHING. IT WAS ALSO REPORTED, THE CURRENT POSITION MAKES REFILLS MORE CHALLENGING AS THE PUMP WAS TILTING FORWARD. PER THE HEALTHCARE PROVIDER (HCP) THERE WERE NO PRODUCT ISSUES OR CONCERNS. APPROXIMATELY 2-3 MONTHS AGO THE PATIENT HAD A FALL AND THE HCP BELIEVED THE SUTURES HOLDING THE PUMP IN PLACE MAY HAVE COME LOOSE OR DISLODGED, CAUSING THE PUMP TO TILT FORWARD. IT WAS NOTED THE PATIENT¿S WEIGHT MAY HAVE BEEN A FACTOR IN CAUSING THIS, AS SHE WAS VERY LARGE WITH A LOT OF TISSUE IN THE ABDOMEN. IT WAS NOTED DURING THE REVISION PROCEDURE, IT WAS OBSERVED THAT ONE OF THE SUTURES SECURING THE SUTURE LOOP HAD BEEN DETACHED AND BELIEVED THIS WAS CAUSED DURING HER FALL. THE EXISTING SUTURES WERE ALL REMOVED USING 2-0 PROLE NE. FOUR OF THE SUTURE LOOPS WERE RE-SECURED, AND THE PUMP WAS REPOSITIONED WITHIN THE EXISTING CAPSULE. THERE WERE NO PATIENT SYMPTOMS OF COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE PATIENT WAS STILL RECEIVING EFFECTIVE THERAPY AND THERE WERE NO ISSUES. THE PUMP WAS BEING USED TO DELIVER MORPHINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662240 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention