BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL DX

    MDR report key: 3924257 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15167
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 DURING A ROUTINE UPGRADE TO A BI-VENTRICULAR SYSTEM, IT WAS NOTED THAT THE ATRIAL LEAD HAD FRACTURED. UPON OPENING THE POCKET, INSULATION DAMAGE WAS ALSO OBSERVED ON THE LEAD. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400583 TENDRIL DX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1388TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR