BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 4121481 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07777
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCE OUT OF RANGE AND LOSS OF VENTRICULAR CAPTURE. THE LEAD WAS NOT IMPLANTED AND PHYSICIAN ELECTS TO USE ANOTHER LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32255 ISOFLEX S PERMANENT PACEMAKER ELECTRODE, NVN NVN ST. JUDE MEDICAL, INC., CRMD 1646T/52

    Patients

    Seq Age Sex Outcome Treatment
    1