BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1895591 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04277
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 13, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    T-WAVE OVERSENSING, NOISE, AND LOW IMPEDANCE WERE REPORTED. THE PHYSICIAN SUSPECTED INSULATION DAMAGE BUT ELECTED NOT TO REPLACE THE LEAD AT THIS TIME SINCE THE PATIENT WAS IN POOR CONDITION DUE TO NON-CARDIAC REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1572/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1