BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1080251 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04223
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.,
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PUMP REPLACEMENT SURGERY, THE CATHETER WAS TESTED AND FOUND TO BE PATENT. THE OLD CATHETER WAS CONNECTED TO THE NEW PUMP USING A REVISION KIT. THE PUMP WAS FILLED WITH 20MLS OF MORPHINE. SINCE THE REPLACEMENT SURGERY, THE PATIENT EXPERIENCED UNSPECIFIED UNDERDOSE SYMPTOMS. THREE WEEKS AFTER SURGERY, THE HCP INTERROGATED AND ASPIRATED THE PUMP RESERVOIR; THE EXPECTED RESERVOIR VOLUME WAS 12MLS, THE ACTUAL RESERVOIR VOLUME WAS 20MLS. THERE WAS NO ALARM OR ERROR MESSAGE FROM THE PUMP SINCE IMPLANT. THE PATIENT WAS TAKEN TO SURGERY IN 2008. THE CATHETER WAS DISCONNECTED FROM THE PUMP; "LIQUOR" FLOWED BACK THROUGH THE CATHETER. A SINGLE BOLUS WAS PROGRAMMED TO VERIFY THAT THE PUMP "CARRIED THE FLUID"; IT WAS "OK". A NEW PUMP CONNECTOR WAS ATTACHED TO THE PUMP. IT WAS VERIFIED THAT THE PUMP "CARRIED FLUID" THROUGH THE NEW CONNECTOR. THE CATHETER WAS THEN CONNECTED. THEY ASPIRATED THE CATHETER VIA THE SIDE PORT AND FOUND IT TO BE "OK". THEY TEMPORARILY CLAMPED THE SPINAL SEGMENT OF THE CATHETER TO CREATE PRESSURE ON THE CONNECTOR TO ENSURE THERE WERE NO LEAKS; IT WAS "OK". THE PATIENT WAS TO FOLLOW-UP WITH THE HCP FOR A REFILL AT ABOUT THREE WEEKS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8578| EXPLANTED