BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3923233 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14545
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 22, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP. UPON INTERROGATION, THE PROGRAMMER DISPLAYED AN ALERT FOR LOW LEAD IMPEDANCE ON THE VENTRICULAR LEAD. DURING IMPEDANCE AND THRESHOLD TESTS, THE PATIENT EXPERIENCED MUSCLE STIMULATION. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401987 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR