BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1223144 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03733
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 25, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STORED EGM REVEALED NOISE ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE ANY INAPPROPRIATE THERAPY. THE NOISE COULD NOT BE REPRODUCED IN THE CLINIC WITH ISOMETRIC TESTING. R-WAVE SENSING, CAPTURE THRESHOLDS, AND SENSE/PACE LEAD IMPEDANCE ALL WERE NORMAL. THE PATIENT WILL BE MONITORED AND ASSESSED AT THE NEXT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1