BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3000379 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03607
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012; CATHETER MODEL 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED. ACTUAL RESIDUAL VOLUME (ARV) WAS 10ML, EXPECTED RESIDUAL VOLUME (ERV) WAS 3ML AT THE FIRST REFILL FOLLOWING IMPLANT. IT WAS NOTED THAT AT IMPLANT THE DEVICE WAS FILLED WITH SALINE AND THEN FILED WITH DRUG 'A COUPLE DAYS LATER.' PATIENT WAS 'NOT GETTING GOOD THERAPY,' SYMPTOMS WERE 'NON OPTIMAL PAIN RELIEF.' THE DAY AFTER THE INITIAL REPORT, IT WAS NOTED THAT A DYE STUDY WAS DONE, THEY WERE ABLE TO ASPIRATE AND INJECT THE DYE AND FOUND NO PROBLEM WITH THE CATHETER. TWO DAYS AFTER THE INITIAL REPORT WAS MADE IT WAS NOTED THAT BOTH DRUG AND CEREBRAL SPINAL FLUID WERE EASILY ASPIRATED THROUGH CATHETER ACCESS PORT AND THEN THE DYE WENT INTRATHECAL. IT WAS THEN NOTED THAT THE DOSE WAS 'SLIGHTLY' INCREASED AND WILL CHECK FOR VOLUME DISCREPANCY AT NEXT REFILL. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103110 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1