BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 3924064 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14985
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 8, 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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED UNACCEPTABLE THRESHOLDS AND HIGH IMPEDANCE. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS FEELING GOOD DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399552 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR