BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4231266 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18085
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 11, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). EVALUATION DESCRIPTION INCLUDED. NO COMPLAINT WAS RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE LEAD WAS RETURNED IN TWO PIECES. INSULATION DEGRADATION WAS NOTED AT THE DISTAL END OF THE CONNECTOR BOOT, 4.5 CM FROM THE CONNECTOR PIN.

    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
    715921 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1882TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1