BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1223821 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03465
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 30, 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 Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE LEAD INSULATION WAS ABRADED AT 5.5 CM FROM THE CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH THAT OF FRICTION TO THE CAN. THE PROXIMAL COIL WAS EXPOSED. THE INSULATION WAS ALSO CUT AT 14.5 CM WHICH WAS FOUND TO BE CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE. THE PATIENT'S EJECTION FRACTION INCREASED, SO THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM AS IT WAS NO LONGER NEEDED.

    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/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1