BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1050479 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01455
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 19, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 LEAD EXHIBITED CONSIDERABLE VARIATION IN REAL-TIME MEASUREMENTS (500-1000 OHMS). THRESHOLDS VARIED FROM 0.5 V TO 3.5 V IN THE BIPOLAR CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1488TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention