BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3923837 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14813
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE LEAD WAS RETURNED IN TWO PIECES. THE INSULATION WAS ABRADED AT 9.0 CM TO 11.2 CM FROM THE CONNECTOR PIN OF THE PART A RETURNED PORTION OF THE LEAD. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE. RELIABILITY LABORATORY TECHNICIAN. (B)(6).

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401629 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1