BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2083846 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-03242
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    February 9, 2011
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. RELIABILITY LABORATORY TECHNICIAN;(B)(4) NO COMPLAINT WAS RECEIVED WITH RETURNED OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND INSIDE-OUT INSULATION ABRASIONS AT 9.1CM TO 10.3CM AND 7CM TO 9.4CM FROM THE HELIX TIP. THE RING CABLES AND RV CABLES WERE NOT ABRADED IN THESE AREAS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1