BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 2905311 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00517
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 8, 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
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 14.5 CM TO 14.6 CM NEAR THE DISTAL END, DUE TO FRICTION WITH ANOTHER DEVICE. THIS WOULD HAVE CAUSED THE PROBLEMS THAT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE DUE TO AN INSULATION BREAK. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10955 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention