BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 1895662 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04453
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 NOISE WAS OBSERVED ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS. THE NOISE WAS ALSO OVERSENSED ON THE VENTRICULAR CHANNEL AND LED TO HV THERAPY. BOTH LEADS WERE CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 1688TC/46, (B)(4)