BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2983855 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01505
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 5, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    NA
    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

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND IMPEDANCE GREATER THAN 4000 OHMS. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87396 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR