BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 1896262 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05219
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    July 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    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 ATRIAL LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE AND NOISE AT IMPLANT. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IMPLANTED AND PROGRAMMED THE SYSTEM TO VVI MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR