BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1220439 · Received November 4, 2008

    Report

    Report Number
    3004209178-2008-07164
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    August 25, 2008
    Report Date
    October 7, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POOR SPASTICITY MANAGEMENT. THE PATIENT WAS TAKEN TO SURGERY. THE CATHETER APPEARED TO BE "FUNCTIONING FINE:"; WITH NO DIFFICULTY ASPIRATING THE CATHETER AND GOOD SPONTANEOUS FLOW. WHEN THE HCP ATTEMPTED TO ASPIRATE FROM THE SIDE PORT, MANY BUBBLES WERE OBTAINED AND HE DID NOT GET VERY MUCH CEREBROSPINAL FLUID UPON ASPIRATION. AS IT APPEARED THAT THE CATHETER WAS WORKING WELL, THE CATHETER WAS RE-CONNECTED TO THE SAME PUMP. IT WAS STILL DIFFICULT TO ASPIRATE THROUGH THE SIDE ARM. AGAIN, AIR BUBBLES WERE ASPIRATED WITH NO CONSISTENT STEADY FLOW OF CEREBROSPINAL FLUID. IT WAS FELT THAT THERE WAS A POSSIBLE CAP MALFUNCTION/BACLOFEN PUMP MALFUNCTION. IT WAS ALSO NOTED THAT THE "REDUNDANT SHUNT TUBING" WAS QUITE COILED IN THE SCAR TISSUE. THIS WAS FRED UP AND THE TUBING WAS EXTENDED TO ITS FULL LENGTH THE SAME RESULT WAS OBTAINED WHEN THE SIDE PORT WAS ACCESSED. THERE WAS NO EVIDENCE OF A MICROFRACTURE OR LEAKING FROM THE TUBING. THE CATHETER WAS INJECTED WITH ISOVUE-M AND CONFIRMATION OF GOOD FLOW INTO THE SUBARACHNOID SPACE WAS MADE. THE HCP AGAIN ATTACHED THE TUBING TO THE EXISTING PUMP; AGAIN WAS ONLY ABLE TO ASPIRATE AIR BUBBLES AND MINIMAL CSF. THE PUMP WAS THEREFORE REPLACED AND FILED WITH 500 MCG/ML OF BACLOFEN. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING DELIVERED PRIOR TO THE SURGERY WERE NOT REPORTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND IT WAS NOTED THAT THE PUMP WAS GOING TO BE REPROGRAMMED ONCE HE AWOKE IN THE RECOVERY ROOM. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC| EXPLANTED: