BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3872168 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11559
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 19, 2007
    Report Date
    May 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED SINCE IMPLANT THE PUMP ¿HITS RIBS¿ WAS UNCOMFORTABLE AND HURTS THE PATIENT WHEN THEY BEND. IT WAS NOTED THAT THE PATIENT WANTED ¿IT OUT.¿ IT WAS ALSO REPORTED THAT THE PUMP HAD BEEN MOVED A COUPLE OF TIMES PREVIOUSLY BUT THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH HEALTHCARE PROFESSIONAL (HCP) OR MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349710 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention