BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2240020 · Received September 8, 2011

    Report

    Report Number
    2017865-2011-05556
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    July 18, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 RIGHT ATRIAL LEAD CAPTURE THRESHOLDS GRADUALLY INCREASED FROM 1.5 V, 0.4 MS TO 5.5 V, 0.4 MS IN THE BIPOLAR CONFIGURATION. THE PATIENT'S PULSE GENERATOR WAS PROGRAMMED TO 7.5 V, 0.4 MS AND A PATIENT FOLLOW-UP WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR