BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1050469 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01450
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, INTERMITTENT LOSS OF ATRIAL SENSING AND INTERMITTENT LOSS OF ATRIAL CAPTURE AT 5 V, 0.5 MS WAS OBSERVED ON THE ECG. ATRIAL SENSING WAS PROGRAMMED TO 0.5 MV IN THE BIPOLAR CONFIGURATION. THE PATIENT WAS ASYMPTOMATIC. DURING PATIENT'S FOLLOW-UP IN 2008 AND ONE MONTH LATER, NO LOSS OF ATRIAL SENSING WAS OBSERVED.

    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 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1