BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 3926296 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15580
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION EXPOSING THE OUTER COIL AT 39.9 CM TO 40.2 CM FROM THE CONNECTOR PIN. THE ABRASION IS CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE. (B)(4). (B)(6).

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404837 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1646T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1