BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 3223249 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04948
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 15, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION ON (B)(6) 2014 NOTES DURING FOLLOW-UP THE ATRIAL LEAD EXHIBITED NOISE ONCE AGAIN. THE DEVICE WAS REPROGRAMMED AND THE PATIENTS CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. THE LEAD WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324613 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1642T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1