BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3001786 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03628
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 3004209178-2012-01916 AND PERTAINS TO THE PATIENT'S SECOND PUMP. [ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ANOTHER PUMP REVISION DUE TO ANOTHER PUMP POCKET ISSUE. REPORTER INITIALLY STATED THAT THE PUMP WAS PROTRUDING OUT OF THE PATIENT'S BODY AGAIN, "FOR THE 4TH TIME", STARTING ABOUT ONE MONTH PRIOR TO THE REPORT DATE. REPORTER STATED THAT PUMP POCKET ISSUES HAD BEEN HAPPENING ABOUT ONCE A YEAR. IT WAS LATER REPORTED THAT THE PATIENT HAD A BLISTER FORMED ON THE SKIN, WHICH WAS A DESCRIPTION OF THE PREVIOUSLY REPORTED EVENT. THE SAME BLISTER ISSUE OCCURRED AGAIN, AND THE PUMP WAS SUBSEQUENTLY REPLACED AGAIN ON (B)(6) 2012. THERE WAS NO INFECTION, SO THE PUMP WAS JUST "MOVED TO THE OPPOSITE SIDE". IT WAS UNCLEAR WHY THE PUMP WAS REPLACED IN ADDITION TO THE POCKET REVISION. NO TROUBLESHOOTING WAS DONE. FOLLOWING THE REVISION, THE PATIENT "WAS DOING FINE WITH NO WITHDRAWAL." CONCERNING THE PATIENT'S FIRST PUMP, IT WAS REPORTED THAT THE PATIENT HAD A BLISTER OR SORE OVER THE PUMP, AND THE PUMP "STARTED TO COME THROUGH THE SKIN". IT WAS UNKNOWN WHEN THE EROSION FIRST STARTED TO APPEAR. THE PUMP WAS REPLACED IN (B)(6) 2009, AND THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105481 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Required Intervention