BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1896087 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04260
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND INSULATION ABRASIONS BETWEEN 9.1CM AND 9.5CM, 35.5CM AND 37.0CM, AND 50.8CM AND 54.0CM FROM THE CUT END OF THE DISTAL PART. HOLES DUE TO ABRASION WERE FOUND UNDER THE DISTAL SHOCK COIL. AT APPROXIMATELY 5CM FROM THE TIP, ONE OF THE TWO SENSING CABLES WAS ABRADED INTO THE METAL WHICH COULD CAUSE THE REPORTED OVERSENSING. THE LEAD COULD NOT BE ELECTRICALLY MEASURED DUE TO THE DAMAGE.

    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 RECEIVED A SHOCK. UPON INTERROGATION FIVE VF EPISODES WERE OBSERVED. THE REVIEW OF THE EGMS REVEALED THAT THE VF EPISODES WERE NOT REAL VENTRICULAR ARRHYTHMIAS, BUT MISCLASSIFIED EPISODES OF NOISE. NOISE WAS NOT REPRODUCIBLE. A FLUOROSCOPY REVEALED NO EVIDENCE OF LEAD DAMAGE. THE PHYSICIAN DECIDED TO REPROGRAM THE ICD. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention