BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4251450 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21614
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 23, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF PAIN RELIEF. ON (B)(6) 2014, FLUOROSCOPY WAS PERFORMED AND THE HEALTHCARE PROFESSIONAL WAS UNABLE TO ASPIRATE OR INJECT AS THE CATHETER WAS COMPLETELY OCCLUDED. ON (B)(6) 2014, SURGICAL INTERVENTION WAS PERFORMED TO SPLICE THE CATHETER. THE SEVERITY WAS NOTED AS MODERATE AND RELATED TO THE DEVICE/THERAPY. AS OF (B)(6) 2014, THE PATIENT RECOVERED WITHOUT SEQUELAE AND PAIN WAS WELL CONTROLLED. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738220 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention