BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 2905052 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00656
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    September 4, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 55.5 CM TO 56.3 CM FROM THE CONNECTOR PIN. THE PROXIMAL COIL WAS EXPOSED IN THE SAME AREA. THE ABRASION IS CONSISTENT WITH THAT OF EXPOSURE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12545 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention