BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 1051036 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01345
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 5, 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
    GA
    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 THE PATIENT RECEIVED ANTITACHYCARDIA PACING (ATP) THERAPY IN RESPONSE TO A VENTRICULAR TACHYCAR- DIA EPISODE. AFTER THE ATP THERAPY, THE EGM SHOWED INHIBITION ON THE VENTRICULAR CHANNEL DUE TO CROSSTALK. THE EGM ALSO SHOWED ATRIAL AND VENTRICULAR SENSING OCCURRING SIMULTANEOUSLY. THE ATRIAL OUTPUT WAS REDUCED.

    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 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1