BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 3925854 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15682
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 27, 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 Occupation
    PHYSICIAN

    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 RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS DEACTIVATED AND A NEW LEAD WAS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404158 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1