BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1831081 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03225
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THERE WERE SEVERAL ABORTED EPISODES OBSERVED. REVIEW OF THE EGMS NOTED NOISE ON THE LEADS. THE AMPLITUDE OF THE NOISE WAS GREATER THAN/EQUAL TO THE AMPLITUDE OF THE TRUE CARDIAC EVENT. BECAUSE THE DEVICE CAN NOT BE PROGRAMMED TO AVOID THE NOISE THE LEADS WERE REPLACED.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 1688TC/52, (B)(4)