BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3844146 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09998
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L81295, IMPLANTED: 2000-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THE PATIENT WAS EXPERIENCING RADICULAR PAIN LATELY. THE PUMP HAD BEEN USED TO SO LONG WITH HEAVILY CONCENTRATED MORPHINE THAT AN MRI WAS BEING PERFORMED TO RULE OUT A GRANULOMA. THEY WERE IN THE PROCESS OF DIAGNOSING AND STATED IT WAS UNKNOWN IF THE SYMPTOMS WERE RELATED TO THE THERAPY. THE MEDICATIONS INFUSED WERE BUPIVACAINE AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322004 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other