BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2991398 · Received March 6, 2013

    Report

    Report Number
    3007566237-2013-00695
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8596SC, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NORMAL PUMP REPLACEMENT, THE PHYSICIAN ACCIDENTALLY CUT THE EXISTING CATHETER. THEY OPENED A PUMP SEGMENT REVISION KIT AND CUT 26 CENTIMETERS (CM), SO THEY PRIMED 40 CM. IT WAS NOTED THAT IT WAS TOO SHORT OF A CONNECTION TO BEGIN WITH SO THEY WERE ABLE TO ADD MORE LENGTH. AFTER THEY PRIMED THE 0.088 MILLILITERS (ML), THE TIP WAS NOT DRIPPING ANY MEDICATION AND THEY WERE UNSURE WHY. THEY WAITED AND THEN PRIMED 5 MORE CENTIMETERS, AND STILL NO DRUG CAME OUT OF THE CATHETER. A COUPLE MINUTES LATER THEY SAW THE MEDICATION COME OUT AND THEY CONNECTED THE CATHETER FLUID TO FLUID. THE CALLER NOTED BEING TOLD AFTER THE CASE THAT THEY WERE SUPPOSED TO HAVE ADDED 7.6 CM ON TO THE 66 CM LENGTH. IT WAS CONFIRMED THAT THERE WAS NO NEED TO HAVE ADDED 7.6. IT WAS QUESTIONED WHY THEY HAD TO PROGRAM AN EXTRA PRIME. THE CALLER WAS SURE THE BACK TABLE PRIME WAS DONE AND THEY WERE BEYOND THE NECESSARY TIME. THE PUMP SYSTEM WAS BEING USED TO DELIVER CLONIDINE, BUPIVACAINE, AND DILAUDID. ADDITIONAL INFORMATION WAS RECEIVED THAT NOTED THEY WERE NOT SURE ON THE EXACT CONCENTRATION AND DOSING. THE PATIENT WAS DOING WELL AND NEVER HAD ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95554 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR