BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3031059 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04479
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8703W LOT# L62221, IMPLANTED: 1999 (B)(6), EXPLANTED: 2013 (B)(6). (B)(4). CATHETER ISSUE - IT WAS NOT CLEAR EXACTLY WHAT THE PROBLEM WAS.

    Additional Manufacturer Narrative · 1

    (B)(4) NO LONGER APPLIES TO THIS EVENT.

    Description of Event or Problem · 1

    AT A REGULAR REFILL, THE DOCTOR ASPIRATED OLD DRUG FROM DEVICE AND IT WAS "RUST" COLORED, IT WAS ALSO NOTED THAT THE EXPECTED RESIDUAL VOLUME WAS 4ML AND THE ACTUAL RESIDUAL VOLUME WAS 10ML. THE DOCTOR SENT THE FLUID TO THE LAB FOR ANALYSIS (CULTURE) NO RESULTS WERE REPORTED. IT WAS NOTED THERE WAS NO TRAUMA RELATED TO THE EVENT. THE DEVICE WAS REFILLED AT THAT TIME, WITH A PLAN TO MONITOR THE PUMP AND AT THE NEXT REFILL ((B)(6) 2013) PLANNED TO RINSE THE RESERVOIR WITH PRESERVATIVE FREE NORMAL SALINE AND DECIDE IF ANY FURTHER ACTION NEEDS TO BE TAKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED, THE PATIENT WAS "DOING OK." THE PATIENT HAD BEEN ON ORAL BACLOFEN AS WELL AS THE INTRATHECAL LIORESAL. IT WAS THEN ADDED SIXTEEN DAYS AFTER THE INITIAL REPORT THAT THERE WAS A CATHETER ISSUE, THAT IT WAS NOT CLEAR EXACTLY WHAT THE PROBLEM WAS. THE PATIENT WAS DISPLAYING SYMPTOMS OF WITHDRAWAL, INTERMITTENT MEDICATION DELIVERY AND INCREASED SPASTICITY SO THE DOCTOR DECIDED TO REPLACE THE ENTIRE CATHETER. THE CATHETER WAS DISCARDED BY THE CUSTOMER. THE PATIENT STATUS AS OF THE DATE OF THIS REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO ISSUE WITH THE PUMP, AND THAT THE CATHETER WAS REPLACED BECAUSE IT WAS DISCONNECTED AT THE PUMP, AND THE PHYSICIAN FELT THAT THE CONNECTION MAY HAVE BEEN FAULTY. THEY ALSO NOTED THAT IN ADDITION, IT WAS A "VERY OLD CATHETER", THUS THEY REPLACED IT ON (B)(6) 2013. THE REPORTER STATED THAT BY "FAULTY", THEY SAID NOT IN THE SENSE THAT THE CATHETER WAS DEFECTIVE, BUT THAT THE CONNECTION HAD COME LOOSE OVER TIME. IT WAS NOTED THAT THE ACTUAL CAUSE FOR THIS WAS UNDETERMINED. IT WAS ALSO NOTED THE PATIENT WAS NOT TAKING ORAL MEDICATIONS, AND SINCE THE REPORTER TOOK OVER CARING FOR THE PATIENT IN 2005, THEY HAVE ONLY HAD LIORESAL IN THE DEVICE. AT THE TIME OF THE CATHETER REVISION, THERE WAS LIORESAL, 2000 MCG/ML AT 1100 MCG/DAY. THE FLUID IN THE PUMP AT THAT TIME WAS CLEAR WITH SOME RUST COLORED STREAKS. THIS FLUID WAS REMOVED AND CULTURED, AND IT WAS NOTED THERE WAS NO GROWTH AND NOTHING FOUND IN THAT FLUID. NO PUMP ISSUE WAS SUSPECTED OR ALLEGED.

    Description of Event or Problem · 1

    THE PATIENT STATED IN (B)(6) 2013, THERE WAS A "PUMP FAILURE". THEY THEN STATED THE CATHETER BECAME UNATTACHED FROM THE PUMP AND HAD BEEN LEAKING FOR SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135121 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention