BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2017865-2008-02245

    MDR report key: 1073461 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02245
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 22, 2008
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED CAPTURE AND SENSING ANOMALIES DUE TO DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention