BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2931909 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01062
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    December 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED CORING, TEARS, AND/OR CUTS IN THE SEAL OF THE PUMP CONNECTOR DUE TO THE OUTLET PORT. THIS WAS NOT THOUGHT TO BE USER RELATED. THE FLAP OF MATERIAL CREATED BY THE CORING MOST LIKELY WAS THE CAUSE OF THE OCCLUSION NOTED BY THE CUSTOMER. CATHETER OCCLUSION WAS VERIFIED IN LAB TESTING.

    Description of Event or Problem · 1

    A CATHETER OCCLUSION AT THE DISTAL SEGMENT WAS REPORTED. IT WAS NOTED THAT A DYE STUDY WAS PERFORMED DURING 'ROUTINE MAINTENANCE REPLACEMENT' TO CHECK FOR CATHETER PATENCY, AND IT REVEALED A CATHETER OCCLUSION. THE CATHETER WAS REPLACED INTRAOPERATIVELY. NO PATIENT SYMPTOMS OR INJURIES WERE NOTED TO HAVE BEEN RELATED TO THIS EVENT, AND THE PATIENT STATUS WAS REPORTED TO BE ALIVE AND WITHOUT INJURY. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37870 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR