BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3853661 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10251
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    June 2, 2014
    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

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    DISCOMFORT AT THE PUMP SITE WAS REPORTED. PART OF THE LATERAL ASPECT OF THE PATIENT¿S PUMP WAS UNCOMFORTABLE AND THE PATIENT FELT THAT IT WAS TOO SUPERFICIAL. NO DIAGNOSTICS WERE PERFORMED. THE ETIOLOGY WAS INDICATED TO BE RELATED TO THE DEVICE OR THERAPY. THE SEVERITY WAS NOTED AS MILD. THE PUMP WAS USED TO DELIVER CLONIDINE. IT WAS FURTHER REPORTED NO ACTION HAD BEEN TAKEN AND THE EVENT WAS ONGOING. IT WAS LATER REPORTED THAT SURGICAL REPOSITIONING OF THE DEVICE TOOK PLACE ON 2014 (B)(6).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT, ON (B)(6) 2014, THE EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332824 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention