BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 2240293 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05487
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 28, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 PATIENT PRESENTED WITH AN ATRIAL LEAD IMPEDANCE GREATER THAN 2500 OHMS AND NO ATRIAL CAPTURE AT 5.0 V IN BOTH THE UNIPOLAR AND BIPOLAR CONFIGURATIONS. A LEAD FRACTURE WAS SUSPECTED. THE PATIENT PRIMARILY USES THE LEAD FOR SENSING. THE LEAD WILL BE MONITORED.

    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 1488TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR