BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3943824 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13227
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8575, LOT # N105436, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_ UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S CATHETER WAS DISLODGED. IT WAS NOTED THAT THE DISLODGED CATHETER HAD A GROWTH MASS OVER THE END OF IT. THE PATIENT KNEW ABOUT THE CATHETER DISLODGMENT SINCE THEIR HEALTH CARE PROFESSIONAL (HCP) WAS ¿GOING TO DO IT¿ BACK IN MAY. A CT SCAN THE PATIENT RECENTLY HAD FOUND THE MASS. IT WAS NOTED THAT A MANUFACTURER¿S REPRESENTATIVE AT THEIR HCP OFFICE SAID IF THEY WENT TO RESTART IT, THE PUMP WOULD HAVE TO CALIBRATE AT APPROXIMATELY 3 MG/DAY BECAUSE OF THE CONCENTRATION. THE PATIENT REPORTED THAT THEY THOUGHT THE EVENT TIME WAS APPROXIMATELY (B)(6). IT WAS NOTED THAT THEY THEN TURNED IT DOWN TO TRY TO SAVE THE LIFE OF THE BATTERY A LITTLE BIT LONGER. THE PATIENT¿S HCP HAD TO CANCEL THEIR PUMP REPLACEMENT SURGERY DUE TO AN EMERGENCY. THE PATIENT REPORTED THEIR PUMP BATTERY WAS DUE TO DEPLETE ON (B)(6) 2014. THE PATIENT NOTED THAT THEY COULDN¿T GET A REPLACEMENT SURGERY UNTIL THE END OF JULY. THE PUMP WAS CURRENTLY USED TO INFUSE MORPHINE AT A DOSE OF 17 MG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422064 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Other