BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1073458 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02242
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 8, 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
    LA
    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 SYMPTOMATIC PATIENT PRESENTED WITH UNIPOLAR VENTRICULAR PULSE AMPLITUDE PROGRAMMED TO 2.0 V AT 0.4 MS. AT THE LAST INTERROGATION IN 2006, VENTRICULAR UNIPOLAR CAPTURE THRESHOLD WAS 7.5 V AT 0.4 MS. THE DOCTOR ELECTED TO EXTEND THE AV AND PV DELAYS, AND INCREASE THE ATRIAL AND VENTRICULAR OUTPUTS. CAPTURE WAS NOT OBSERVED IN EITHER CHAMBER AT HIGHER OUTPUTS. THE PATIENT HAD A STABLE INTRINSIC RHYTHM, AND WAS DISCHARGED.

    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/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1