BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 3915825 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08525
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    June 14, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION INCLUDED. LEAD ANALYSIS REVEALED OUTER INSULATION ABRASION CONSISTENT WITH DAMAGE CAUSED BY FRICTION WITH ANOTHER DEVICE. ELECTRICAL VALUES WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION. THE CHRONIC VENTRICULAR LEAD WAS NOT ASSOCIATED WITH THE INFECTION. IT WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38519 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION 1388TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention 5626 2373458