BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830715 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03299
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    April 19, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVIEW OF STORED EGMS SHOWED OVERSENSING ON VENTRICULAR CHANNEL. LEAD ISSUE SUSPECTED. THE PATIENT WAS AT AN AMUSEMENT PARK AND RODE SEVERAL RIDES THE DAY BEFORE THE OVERSENSING ISSUE OCCURRED. THE PACING LEAD IMPEDANCE HAS DECREASED AND CAPTURE THRESHOLD INCREASED. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS. A CHEST X-RAY WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR