BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1895986 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04264
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 3, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO EPISODES OF NOISE CLASSIFIED AS VF. THE PATIENT DID NOT RECEIVE THERAPY FOR THE NOISE. THE NOISE COULD BE REPRODUCED IN CLINIC. THE PATIENT WAS SENT TO ANOTHER PHYSICIAN IN ANOTHER CITY TO FIND THE BEST RESOLUTION.

    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 72 YR