BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 2905059 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00507
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 5, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. AN INSULATION ABRASION WAS NOTED AT 9 CM TO 11 CM FROM THE DISTAL TIP. ABRASIONS ARE CONSIST TENT WITH CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    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
    11623 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1