BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1895549 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04266
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 8, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EXPERIENCE WAS CONFIRMED IN THE LABORATORY. A CONTINUITY CHECK INDICATED THAT THE DISTAL COIL WAS OPEN. VISUAL INSPECTION NOTED THE LEAD WAS CRUSHED AT 38CM FROM THE CONNECTOR PIN. ONE OF THE RV CABLES AND ONE OF THE SVC CABLES WERE ALSO FRACTURED. THE FRACTURE IS CONSISTENT WITH THAT OCCURRING DUE TO CLAVICLE CRUSH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, THE PACING LEAD IMPEDANCE, SENSING, AND PACING THRESHOLDS WERE ABNORMAL. SUSPECTED INSULATION BREAK. AN X-RAY SHOWED THE RV LEAD WAS CRUSHED UNDER THE CLAVICLE. THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    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 73 YR Required Intervention