BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1831128 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03223
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 17, 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 Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS OF THE LEAD REVEALED THE INNER INSULATION AND BOTH PROXIMAL CABLE ETFE COATINGS WERE ABRADED AT 49 CM FROM THE DISTAL TIP ELECTRODE. THE LEAD ABRASIONS ARE CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN. THE CONDITION OF INSULATIONS COULD HAVE CAUSED A SHORT CIRCUIT RESULTING IN CAPTURE AND SENSING ANOMALIES. LEAD IMPEDANCE TEST COULD NOT BE PERFORMED SINCE THE LEAD WAS CUT INTO 2 PIECES AS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER A TERM OF 5 MONTHS, A RAPID INCREASE IN IMPEDANCE WAS OBSERVED. DURING THE FOLLOW-UP, A LOSS OF CAPTURE, HIGH IMPEDANCE AND NOISE WERE OBSERVED. THE LEAD WAS EXPLANTED.

    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 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention