BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2950787 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01494
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN NEAR THE CATHETER TRACT. THE CATHETER WAS REPLACED (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A BURNING PAIN NEAR THE CATHETER TIP. IT WAS NOTED THAT THE EVENT WAS POSSIBLY DUE TO AN INFLAMMATORY MASS. THIS EVENT HAD ALSO RESULTED IN IN-PATIENT HOSPITALIZATION. THE DRUGS USED IN THIS SYSTEM WERE MORPHINE, B UPIVACAINE, BACLOFEN, CLONIDINE, AND DROPERIDOL. SEVENTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE AN INFLAMMATORY MASS. HOWEVER, THE PATIENT'S SYMPTOMS HAD LED THE PHYSICIAN TO BELIEVE IT WAS AN INFLAMMATORY MASS AND THE PATIENT WAS ALREADY AN IN-PATIENT, SO THE REVISION HAD BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE 2013 (B)(6). DROPERIDOL WAS REMOVED FROM THE MEDICATIONS WITHIN THE PUMP 2013 (B)(6). THE INFUSION RATE WAS INCREASED 2013 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54848 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R