BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5210441 · Received November 9, 2015

    Report

    Report Number
    3004209178-2015-22409
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 19, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8709SC CATHETER (B)(4) REVEALED CORING/TEARS/CUTS IN THE SEAL OF THE SUTURELESS CONNECTOR. UNDER MICROSCOPE INSPECTION, A DEEP, CIRCULAR CORING COULD BE SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. PRESSURE TESTING SHOWED THE SC CONNECTOR TO BE LEAKING, MOST LIKELY DUE TO THE CORING. THE FLAP OF MATERIAL CREATED BY THE CORING MAY HAVE CONTRIBUTED TO AN OCCLUSION BUT NO OCCLUSION WAS VERIFIED DURING TESTING. DAMAGE WAS ALSO SEEN ON ONE OF THE RETAINING RING FINGERS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4). THE SUTURELESS CATHETER CONNECTOR WAS RETURNED FOR ANALYSIS. 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING LIORESAL (CONCENTRATION 2000 MCG/ML; DOSE 275) VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS STROKE AND INTRACTABLE SPASTICITY. ON (B)(6) 2015, THE PATIENT WAS TAKEN TO SURGERY FOR A ROUTINE PUMP REPLACEMENT PROCEDURE. DURING THE REPLACEMENT, THE PHYSICIAN NOTICED THAT THE CATHETER WAS NOT FLOWING. AFTER WAITING FOR SEVERAL MINUTES, HE DISCONNECTED THE 7.6 CM SUTURELESS CONNECTOR. ONCE DISCONNECTED, THE CATHETER STARTED FLOWING IMMEDIATELY. THE PHYSICIAN FELT THAT THE CATHETER WAS OCCLUDED; THAT THERE WAS DEBRIS IN THE CATHETER. THE SUTURELESS CATHETER CONNECTOR WAS REPLACED WITH A NEW 7.6 CM SUTURELESS CONNECTOR. THE ISSUE WAS RESOLVED. THE PATIENT STATUS WAS REPORTED AS "ALIVE-NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741489 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR