BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955023 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00082
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    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 A LEAD STIFFNESS TEST WAS PERFORMED AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVEN DAYS AFTER IMPLANT, A LEAD PERFORATION WAS OBSERVED. THE PATIENT EXPERIENCED PERICARDIAL TAMPONADE. THE LEAD WAS REMOVED DUE TO THE PATIENT'S HEALTH CONDITION.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention