BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2984479 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00387
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 8, 2013
    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

    IT WAS REPORTED THAT PRESENTED WITH BRADYCARDIA. INCREASE IN PACING LEAD IMPEDANCE AND THRESHOLD WERE OBSERVED. DURING LEAD REVISION NO CAPTURE WITH INHIBITION AND NO UNDERLYING RHYTHM WERE NOTED. PATIENT IS PACEMAKER DEPENDENT. X-RAY REVEALED A SHARP BEND IN THE POCKET AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87716 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1