BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1573180 · Received January 9, 2010

    Report

    Report Number
    2017865-2010-00460
    Event Type
    Injury
    Date Received
    January 9, 2010
    Date of Event
    November 6, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VT EPISODE, ATP WAS ADMINISTERED WHICH ACCELERATED THE RHYTHM INTO A VF. THE ICD ATTEMPTED VF THERAPY SIX TIMES, BUT DID NOT CONVERT THE PATIENT. AN ALERT FOR OUT OF RANGE HV IMPEDANCE WAS NOTED ALONG WITH OTHER ALERTS. THE PATIENT WAS RESCUED EXTERNALLY. THE LEAD WAS CAPPED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention V-240