BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3925870 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15670
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 16, 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
    NV, US
    Reporter Occupation
    OTHER

    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 PATIENT WAS PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP, AND UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED NOISE AND FAR R-WAVE OVERSENSING. THE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THE LEAD CONTINUED TO EXHIBIT NOISE WITH INHIBITION OF PACING. THE LEAD WAS PROGRAMMED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404725 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR