BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 1955802 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00696
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 22, 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
    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 THE PACEMAKER DEPENDENT PATIENT PRESENTED EXPERIENCING DIZZY SPELLS. WHILE IN THE EMERGENCY ROOM, A SEVEN SECOND PAUSE ON AN EXTERNAL ELECTROGRAM WAS CAPTURED. NO PACING SPIKES WERE OBSERVED DURING THE PAUSE, LEADING TO THE CONCLUSION OF VENTRICULAR OVERSENSING. NOISE WAS NOT REPRODUCIBLE WITH ISOMETRICS OR POCKET MANIPULATION.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR