BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2904173 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00346
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J0058200R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING INCREASED PAIN. SURGERY WAS DONE ON (B)(6) 2012 IN WHICH IT WAS DISC OVERED THE CONNECTOR FROM THE CATHETER WAS DISCONNECTED FORM THE PUMP. CEREBROSPINAL FLUID WAS UNABLE TO BE ASPIRATED FROM THE CATHETER TO CONFIRM PATENCY, SO THE CONNECTOR OF THE CATHETER WAS REPLACED. NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE PATIENT WAS DOI NG WELL AND HAD ADEQUATE PAIN RELIEF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER HAD DISCONNECTED FROM THE PUMP. IT WAS REPORTED THAT A REVISION WAS PERFORMED WHERE THE CATHETER WAS REPLACED AND THE PUMP WAS MOVED TO THE PATIENT'S BACKSIDE. IT WAS NOTED THAT THERE WAS FLUID BUILDUP IN THE PUMP POCKET, THOUGH IT WAS UNCLEAR WHETHER IT WAS DRUG OR ANOTHER FLUID. IT WAS ALSO MENTIONED THAT THERE WAS SCAR TISSUE THAT HAD FORMED AT THE PROXIMAL END OF THE CATHETER. ONCE THE SURGEON REMOVED THE SCAR TISSUE, THERE WAS FREE FLOW FROM THE CATHETER. THE REPORTER THOUGHT THE FLUID WAS A COMBINATION OF BACKFLOW AND DRUG. IT WAS NOTED THAT THE PATIENT WAS BEING HELD OVERNIGHT FOR OBSERVATION. THE PATIENT HAD BEEN HAVING SOME SYMPTOMS PRIOR TO REVISION, THOUGH NO SPECIFIC SYMPTOMS WERE MENTIONED. THE DRUG USED IN THIS SYSTEM WAS DILAUDID. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11087 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention