BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1191663 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04333
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention