BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 2240330 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05678
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 20, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS REVEALED THAT THE DISTAL INSULATION WAS ABRADED OPEN AT 4.8 CM TO 5.5 CM AND AT 3.3 CM TO 4.3 CM FROM THE DISTAL TIP. THE DISTAL INSULATION WAS ABRADED FROM THE INSIDE FROM PRESSURE AND MOVEMENT AGAINST THE COILS. AN ELECTRICAL SHORT WAS NOTED BETWEEN COILS DUE TO OPEN DISTAL INSULATION WHICH RESULTED IN THE REPORTED IMPEDANCE ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A GRADUAL DECLINE IN BIPOLAR IMPEDANCE TO LESS THAN 200 OHMS AND HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention