BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1955701 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00826
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 NOISE ON THE STORED ELECTROGRAMS. THE NOISE WAS REPRODUCIBLE, AND TRIGGERED 5,360 NOISE REVERSIONS SINCE THE LAST FOLLOW-UP IN (B)(6), 2010. IN (B)(6), NOISE WAS NOT REPRODUCIBLE, BUT THERE WERE A FEW HUNDRED NOISE REVERSIONS. THE PATIENT REPORTED FEELING DIZZY SINCE THE LAST FOLLOW-UP.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR