BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220239 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04158
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 10, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 TO THE ER DUE TO OUT OF RANGE HV LEAD IMPEDANCE. THE PATIENT RECEIVED THREE SHOCKS. THE FIRST TWO DID NOT CONVERT THE ARRYTHMIA BUT THE THIRD SHOCK DID. PRINTOUT MESSAGE FOR HV LEAD IMPEDANCE WAS OBSERVED. LEAD AND DEVICE WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321034 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention V-193, 261117