BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1032361 · Received April 22, 2008

    Report

    Report Number
    3004209178-2008-02124
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SYSTEM WAS REMOVED DUE TO STAPH INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3389S| LEAD MODEL 3389S| EXTENSION MODEL 7482| EXTENSION MODEL 7482| EXPLANTED