BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1223486 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03226
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    July 23, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    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 WAS IMPLANTED IN THE VENTRICULAR SEPTUM IN 2008. THE NEXT MORNING THE LEAD HAD VISIBLY DISLODGED, AND BY 2008, IT HAD FALLEN COMPLETELY INTO THE VENTRICULAR APEX. THE LEAD ENDED UP IN A STABLE APICAL POSITION WITH GOOD THRESHOLDS AND IMPEDANCE, SO THE PHYSICIAN ELECTED NOT TO REVISE IT.

    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 1688T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1