BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1181203 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06224
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2007
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709| PROGRAMMER MODEL 8840| EXPLANTED