BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3923222 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14536
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 13, 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. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE MIDDLE PORTION OF THE LEAD WAS RECEIVED. AN INSULATION ABRASION EXPOSING OUTER COIL WAS NOTED AT 11.2 CM TO 12.5 CM FROM THE PROXIMAL END. THE ABRASION IS CONSISTENT WITH THAT OF EXPOSURE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE. (B)(4). (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
    401061 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1