BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4181557 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19912
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    April 2, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE CATHETER, MODEL # 8780, SN (B)(4), FOUND NO SIGNIFICANT ANOMALIES. THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, (B)(4), PRODUCT TYPE: CATHETER; PRODUCT ID 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, (B)(4), PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8780, SERIAL# (B)(4) IMPLANTED: (B)(6) 2014, (B)(4), PRODUCT TYPE: CATHETER; PRODUCT ID 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, (B)(4), PRODUCT TYPE: CATHETER. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE SUTURELESS CONNECTER WAS ATTACHED TO THE PUMP THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE CSF (CEREBROSPINAL FLUID) FROM THE CAP (CATHETER ACCESS PORT). THE NEEDLE WAS CHANGED AND THERE WAS STILL NO CSF. THE SC (SUTURELESS CONNECTOR) WAS THEN DISCONNECTED FROM THE PUMP AND THE HCP WAS STILL UNABLE TO ASPIRATE CSF SO THE SC WAS CUT OFF AND A NEW SC WAS ATTACHED. THE HCP WAS THEN ABLE TO ASPIRATE CSF THROUGH THE CAP. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY.¿ THE DEVICE SYSTEM WAS USED TO DELIVER PRIALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661831 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR