BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1223169 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03233
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. ATRIAL SENSING WAS NORMAL INITIALLY, BUT AFTER INTUBATION THERE WAS NO ATRIAL SENSING WHILE THE PATIENT WAS LYING DOWN. DUE TO THE PATIENT'S CONDITION, TESTS WERE NOT PERFORMED IN OTHER POSITIONS.

    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 1488T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1