BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830855 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03273
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    May 4, 2010
    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

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED IMPEDANCE AND NOISE ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND MULTIPLE OUTER INSULATION ABRASIONS ON THE LEAD AT 10CM, 14 CM AND 22 CM FROM THE CONNECTOR PIN. THE IS-1 PROXIMAL, DF-1 SVC AND DF-1 RV CABLES WERE EXPOSED IN THESE AREAS. THE DAMAGE FOUND IS CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCE HAD DECREASED AND NOISE WAS NOTED. DURING RV LEAD EXTRACTION, AN INSULATION BREAK WAS OBSERVED.

    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 56 YR Required Intervention