BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM

    MDR report key: 1154251 · Received September 11, 2008

    Report

    Report Number
    2017865-2008-02966
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    June 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD PERFORATION WAS OBSERVED. THE LEAD WAS REPOSITONED WITHOUT COMPLICATION. THE LEAD WAS MOVED FROM THE APEX POSITION ONTO THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention