BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4223436 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20892
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 15, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# L79681, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    AT THE REFILL ON (B)(6) 2014, A VOLUME DISCREPANCY WAS NOTED WITH THE ACTUAL RESIDUAL VOLUME GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE HEALTHCARE PROFESSIONAL ASPIRATED 18.5; THE EXPECTED VOLUME WAS NOT REPORTED. THE PUMP LOGS WERE CHECKED AND SHOWED A MOTOR STALL AND RECOVERY ON THE SAME DAY IN AUGUST WHEN THE PATIENT HAD AN MRI. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE LAST REFILL WAS IN MAY; WHEN THE ACTUAL RESERVOIR VOLUME WAS 4.2ML AND THE EXPECTED RESERVOIR VOLUME WAS 3.5ML. THE PATIENT HAS EXTREME SCOLIOSIS. THE HCP WAS SETTING UP A CATHETER DYE STUDY. ON (B)(6) 2014, A CATHETER DYE STUDY WAS ATTEMPTED; HOWEVER, THE PATIENT WAS TOO UNCOMFORTABLE TO LIE STILL. ANOTHER DYE STUDY WAS BEING SET-UP TO INCLUDE SEDATION. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. INTERVENTION AND PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707579 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR