BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL LEAD, RIGHT VENTRICULAR

    MDR report key: 1831090 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03621
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 21, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A COMPELETE ANALYSIS COULD NOT BE PERFORMED DUE TO PARTIAL LEAD RETURNED MEASURING 14.4 CM. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    THE LEAD WAS CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    AT FOLLOW-UP DURING DFT TESTING, TWO ALERTS WERE OBSERVED, HV LEAD IMPEDANCE LESS THAN 10 OHMS AND POSSIBLE OUTPUT CIRCUIT DAMAGE. IT WAS NOTED THAT HV LEAD IMPEDANCE CHECKS WERE PERFORMED AFTER THE ORIGINAL DFT BUT WERE BLOCKED WHEN THE MESSAGE POSSIBLE OUTPUT CIRCUIT DAMAGE WOULD APPEAR. NOISE ALSO APPEARED ON THE VENTRICULAR SENSE PACE CHANNEL RIGHT BEFORE THE TESTING. THE PHYSICIAN NOTICED LEAD DAMAGE AND EXPLANTED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVL LEAD, RIGHT VENTRICULAR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RV02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention