BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3053028 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06017
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASED PAIN DESPITE AN INCREASE IN MEDICATIONS. IT WAS STATED THAT THE CATHETER WAS BLOCKED AND THERE WAS POOR BACKFLOW DETECTED DURING A RECENT REFILL. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WITH CONTRAST AND NO GRANULOMA WAS FOUND. THE ISSUE WAS WITH THE INTRATHECAL PORTION OF THE CATHETER, SO A SURGICAL REVISION WAS PERFORMED TO SPLICE THE CATHETER. A CATHETER OCCLUSION WAS NOTED. THE PATIENT RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154229 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention