BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3926174 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15507
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 RIGHT VENTRICLE LEAD EXHIBITED LOW IMPEDANCES AND NOISE. THE LEAD WAS PROGRAMMED TO UNIPOLAR CONFIGURATION AND NOISE WAS STILL PRESENT. NOISE COULD NOT BE REPRODUCED IN CLINIC. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402854 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention