BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL FSR

    MDR report key: 3560007 · Received January 7, 2014

    Report

    Report Number
    2017865-2014-01167
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    October 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT THE RIGHT ATRIAL LEAD EXHIBITED HIGH THRESHOLDS AND UNDER SENSING. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10707 TENDRIL FSR PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1699T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR