BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896207 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05015
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS OF 7.5 V AT 1.2 MS, INTERMITTENT CAPTURE AND NOISE. A CHEST X-RAY FOUND THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT SURGERY, IT WAS OBSERVED THAT THE LEAD WAS TOO LONG WHICH RESULTED IN TOO MUCH SLACK.

    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 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention