BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 3926280 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15592
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 15, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC WITH COMPLAINTS OF PALPITATIONS. THE PATIENT HAD UNDERGONE A SUPER VENA CAVA DILATION WITH A BALLOON DUE TO AN OCCLUSION. POST PROCEDURE, THE RIGHT VENTRICULAR LEAD EXHIBITED MULTIPLE EPISODES OF NOISE REVERSION. THE NOISE WAS REPRODUCIBLE IN CLINIC BY POCKET MANIPULATION. THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404264 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR