BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1050626 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01593
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE ATRIAL LEAD IMPEDANCE WAS 100 OHMS. SEVEN DAYS LATER, THE DEVICE WAS INTERROGATED AGAIN AND NOISE WAS OBSERVED ON THE ATRIAL LEAD. THE LEAD WAS SUBSEQUENTLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention