BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1073133 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02375
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REMOVED DUE TO DISLODGMENT. LOW IMPEDANCE WAS ALSO OBSERVED. IT WAS NOTED THAT THE PATIENT IS A TWIDDLER AND UPON OPENING THE POCKET, THE SVC COIL WAS VISIBLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OPERATOR CUT HER FINGER WHILE CHANGING THE CAP PIERCER BLADE. PART OF THE WICK CAUGHT ON THE BLADE AND SHE TRIED TO REMOVE THE WICK FROM THE BLADE AND CUT HER FINGER. THE OPERATOR WAS TAKEN TO THE ER. NO OTHER DETAILS WERE SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7011/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention