BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL DX

    MDR report key: 2013867 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01352
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED SEVERAL EPISODES OF NOISE AND LOW IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED, AT WHICH TIME, DAMAGE TO THE LEAD WAS NOTED AROUND THE CLAVICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1388T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention