BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 1896493 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05068
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 A PATIENT NOTIFIER WAS DELIVERED SOMETIME AROUND (B)(6) 2010 DUE TO A LOW ATRIAL LEAD IMPEDANCE. THE PATIENT HAD DOCUMENTED A FALL BEFORE (B)(6) 2010, AFTER WHICH PROGRAMMING WAS CHANGED TO VVI. IT WAS SUSPECTED THAT THE LEAD COULD HAVE BEEN DAMAGED DUE TO THE FALL. IN CLINIC, LEAD IMPEDANCES WERE STABLE, BUT NOISE WAS REPRODUCIBLE. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR