BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2890014 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10704
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 THE PATIENT PRESENTED IN CLINIC WITH COMPLETE LOSS OF CAPTURE. SUSPECTED EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. THE LEAD WAS CAPPED AND RE- PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR